Catalog Number 788414 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/24/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the seal was found damaged upon opening of the ureteral stent outer package.
|
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
It was reported that the seal was found damaged upon opening of the ureteral stent outer package.
|
|
Manufacturer Narrative
|
The reported event is confirmed cause unknown.Visual evaluation noted received 1 ureteral stent kit in unsealed open packaging.Therefore, product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be inadequate retention.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Search Alerts/Recalls
|