Catalog Number 0250070500 |
Device Problems
Device Disinfection Or Sterilization Issue (2909); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/07/2014 |
Event Type
malfunction
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Event Description
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It was reported that there was a bug inside the sterile packaging.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Manufacturer Narrative
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The foreign material failure mode was confirmed by the communication of the sales rep.Physical examination of the returned product and additional testing by our team concluded that possible root causes could be attributed to: manufacturing/assembly error, severe shipping conditions, incorrect and inadequate packaging.This was deduced due to risk documents and investigation results.Upon inspection of the received device we were unable to find any bug/gnat.Upon inquiry to the sales rep he confirmed having seen the bug himself taped to the blister package.However, since the blister package was not received the bug was not received.We concluded that the most likely root cause is manufacturing/assembly error due to event description and investigation findings.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence. .
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Event Description
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It was reported that there was a bug inside the sterile packaging.
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Search Alerts/Recalls
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