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Model Number M0063901050 |
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 10/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a zero tip retrieval basket was unpacked for inventory on (b)(6) 2019.According to the complainant, a box of zero tip baskets was received; however, it was noticed that one of the zero tip baskets had a hole in the packaging.Reportedly, the sterility of the device was compromised.The device was not used on a patient or procedure.
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Event Description
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It was reported to boston scientific corporation that a zero tip retrieval basket was unpacked for inventory on (b)(6) 2019.According to the complainant, a box of zero tip baskets was received; however, it was noticed that one of the zero tip baskets had a hole in the packaging.Reportedly, the sterility of the device was compromised.The device was not used on a patient or procedure.
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Manufacturer Narrative
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(b)(4).Visual analysis of the returned device found its original pouch was ripped.The marks indicates that likely the pouch was ripped during manipulation or storage with one sharp object.It is most likely that handling and manipulation of the device during shipping/storage could have contributed to the reported issue since the marks indicates that the pouch was likely ripped during manipulation or storage with a sharp object.Manufacturing processes includes extensive inspections to ensure that all finished devices meet specifications; however, there is no control how the devices are handle or manipulated in the field.Therefore, the most probable root cause is cause traced to transport/storage, since the problem was traced to the inappropriate transport or storage of the device.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
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Search Alerts/Recalls
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