One (1) 8535 reflex one skin stapler was returned for evaluation of "poor sealing." the upper left corner of the packaging tray, opposite the chevron seal was slightly deformed and there was a lack of adhesive transfer in this area.The packaging lab testing results show the device failed the visual inspection and dye leak test, and the seal width was less than 1/4 inch in the corner of the blister tray, thus the complaint is confirmed.The device was manufactured 1-march-2016.A review of the device history record for this lot found no noted discrepancies during the manufacturing process and no non-conformances regarding this product's identity, quality, safety, effectiveness or performance that could have caused or contributed to this reported incident.Of the lot containing (b)(4) units there were no other similar complaints received.(b)(4).The reported packaging anomalies were obvious to the distributor and therefore prompted the return of the devices for evaluation and replacement.To date, there have been no serious injuries or death related to this reported problem.Nonetheless, to prevent future recurrences, an investigation, (b)(4), has been opened to address this issue.
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The distributor in (b)(4) reported that during receiving and inspection of incoming products, 1 package containing a reflex skin stapler 35 wide, was discovered to have "poor sealing." there was no patient involvement in this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.This report is being filed based on the potential injury with recurrence.
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