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Model Number M001271350 |
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 Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: 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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Event Description
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It was reported that a tear was noted on the sterile package.A fr.10/25 cm flexima¿ apdl was selected for use.It was noted that this device package was stuck to another device's package when received after shipping.When attempted to separate the two packages, a tear was noted on the inner sterile package.No patient involvement.
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Search Alerts/Recalls
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