Catalog Number 00450104004 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This report will be amended when our investigation is complete.
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Event Description
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It is reported inner plastic wrapping was damaged; therefore, the sterility could not be confirmed.
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Manufacturer Narrative
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A self drilling pin with packaging contents was returned for review.As returned, the wrap-around label was broken.The tamper proof label was intact.The outer tyvek lid was partially removed.The inner tyvek lid is partially delaminated and attached to the outer lid.The peel tab was sealed between the outer tyvek lid and cavity.This device is used for treatment.No other complaints of this nature have been reported for the part number involved.A stock investigation was attempted for the part/lot combination and no inventory was available to investigate.The lot has been fully distributed with no further reported complaints of this nature.The packaging inspection procedure includes both tyvek/cavity and 100% visual inspections to prevent the reoccurrence of this issue.Root cause has been determined to be a packaging deficiency.
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Search Alerts/Recalls
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