- GeoTec, Inc.
- Issuing Office:
- New England District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
- For report entitled, “Physical Bench Testing Study performed on Banyan Medical Cannula/Trocar new, accelerated and real time aged product, per GeoTec protocol 170004-01”, signed 2/28/2013”:
- Your firm did not have an approved protocol that listed accepted specification criteria to demonstrate the finished products met your approved criteria.
- We observed two separate versions (B) of the same report both dated February 28, 2013. One version included failing bend testing results. The second version did not include the failing data and did not provide any explanation for the failing results.
- For compression testing performed on the cannulas, there was no justification for various differences between the cannulas tested as part of this study; for example, the number of cannulas tested ((b)(4) vs. (b)(4)), the lengths tested ((b)(4) vs. (b)(4)), whether or not the cannulas had sideports, whether or not the samples were sterilized prior to testing, or whether or not the cannulas went through accelerated aging.
- For the mechanical tensile testing performed on the trocars, there was no justification for various differences between the trocars tested as part of this study; for example, the number of devices tested ((b)(4) vs. (b)(4)), the length tested ((b)(4) vs. (b)(4)), the tip type ((b)(4) vs. (b)(4)), or aging ((b)(4)-year accelerated vs. date of manufacture).
- For the mechanical puncture testing performed on the trocars, there was no justification for various differences between the trocars tested as part of this study; for example, the differences in quantities tested ((b)(4) vs.(b)(4)), length ((b)(4) vs. (b)(4)), tip type ((b)(4) vs. (b)(4)), or whether or not the samples were sterilized prior to testing.
- There are no comparisons of results from one specific group to another to demonstrate that the results were within acceptable limits (i.e. test success or failure).
- The Incoming Inspection Report could not be located for the components tested from one group (lot 10040531) of the Mechanical Puncture Test of Trocars.
- For report entitled, “Report of Shelf-Life of Banyan Medical Disposable Cannula and Trocar Accelerated and Real-time Aging Analysis dated 2/4/2013”:
- There is no explanation for three failing sterile package peel strength tests.
- Your firm has not conducted a real time aging study for the Banyan Medical Cannula/Trocars as required by this report. The report summary states that the real timeaging study should be completed by June 14, 2015; however this test has not yet been initiated.
- During review of the DHR for NeuroTherm RFC electrode lot M0070815-21, (b)(4) units failed initial inspection and were reprocessed; however documentation of the rework was not recorded in the DHR.
- Two DHR’s reviewed noted operations were performed on dates prior to the manufacture and/or release of necessary subassemblies. For example, subassemblies for finished goods lot 140721 were picked on July 29, 2014, however parts were not released until ten days later on August 8, 2014. Subassemblies for finished goods lot 140707 were picked on July 21, 2014, however parts were not released until one day later on July 22, 2014.
- During review of DHR’s, we observed two different products with the same lot number, MO070114-03. Your firm’s personnel explained that a lot number should not be used more than once.
- Corrective and Preventive Action (CAPA) Report 1154 was opened on February 10, 2015 to address the return of Endoscopic Disposable Knives. The CAPA stated the customer received 3 lots of devices with the incorrect sterilization dot indicators and noted that ethylene oxide sterilization dots were affixed to the product instead of gamma sterilization dots. Your proposed corrective action was to rework the affected lots. This CAPA was later closed on February 12, 2015 without verifying that all corrective actions were completed. For example, the CAPA included documentation that only two lots were reworked but did not provide a description of the remaining lot (150106).