Catalog Number CDS0705-NTW |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported when the device was received at the hospital, the packaging was damage and the sterility was breached.Therefore, the device was not used.No additional information was provided.
|
|
Manufacturer Narrative
|
All available information was investigated and the reported damaged packaging was confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation determined the reported damaged packaging appears to be related to transportation and/or handling during storage.There is no indication of a product issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|