Catalog Number K08-YS055A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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One device was returned for evaluation.Visual inspection confirmed there was damage to the clear film.The unit was bubble tested and the sterility was found to be compromised.The complaint is confirmed.The root cause is attributed the manufacturing process.The device history record was reviewed, and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.
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Event Description
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The account alleges that during inspection a hole in the clear film packaging was discovered.No patient consequence to report.
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Search Alerts/Recalls
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