Catalog Number K08-MS3243A |
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 10/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device has been returned for evaluation.The device was examined visually.The packaging was bubble tested and the sterility was found to be compromised.The complaint is confirmed.The root cause is attributed to the manufacturing process.The hole appears to have been caused by rough or improper handling after the package was sealed.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents 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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