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 or breach in sterility was not confirmed.However, there was an embedded particulate on the paper material.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific product issue.The investigation determined that the noted embedded particulate on the tyvek pouch was within the abbott vascular particulate and print imperfection standards.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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