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Model Number M001274020 |
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 06/26/2014 |
Event Type
malfunction
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Event Description
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It was reported that a sterlization issue occurred.During unpacking of the flexima¿ device, it was noted that there were holes in the packaging through the sterile field.As there was no contact with the patient, no complications were reported.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Device evaluated by manufacturer - the device returned was inspected, all the seals of the pouch were found sealed, however three couples of holes were found at the package, appeared to be staple holes.A staple was compared over the holes encountered and the holes matched with the staple size.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
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Event Description
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It was reported that a sterilization issue occurred.During unpacking of the flexima device, it was noted that there were holes in the packaging through the sterile field.As there was no contact with the patient, no complications were reported.
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Search Alerts/Recalls
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