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Model Number M001271340 |
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 07/23/2014 |
Event Type
malfunction
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Event Description
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It was reported device sterility was compromised.While unpacking the shipping box, the package of the flexima¿ apdl drainage catheter was found ripped open and the product is no longer sterile.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Search Alerts/Recalls
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