Catalog Number S-55-120-120-P6 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional ten supera devices are being filed under separate medwatch reports.
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Event Description
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It was reported that during an incoming inspection at the distribution center, 11 units of supera self-expanding stent systems (sess) were rejected for sterile packaging damage.The reasons included hole on tyvek (7) and scratched/ blemished tyvek packaging (4).As the damage was noted at the distribution center there was no patient involvement.The sess units were not used.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported packaging damage was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that contributed to this event.Based on review of the similar incidents, there is an indication of a lot specific quality issue.The investigation determined the reported packaging damage on the sealed pouch appears to be related to a potential product quality issue.The issue is being addressed per internal operation procedures.Abbott vascular will continue to trend the performance of these devices.
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Search Alerts/Recalls
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