Catalog Number CDS0702-XTW |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2023 |
Event Type
malfunction
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Event Description
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This is filed to report a hole in the device packaging.It was reported that a mitraclip xtw was received at the hospital with damage to the packaging.It was noted that there was a hole in the shipping packaging, as well as the actual device packaging.There was no patient involvement.No additional information was reported.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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Returned device analysis confirmed the damage to the shelf carton.However, the pouch seals and pouch were intact.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of lot-specific similar complaints identified no other complaints reported from this lot.Based on the available information, a cause for the reported damage to the shelf carton could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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