Catalog Number 777626 |
Device Problem
Wrong Label (4073)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/12/2023 |
Event Type
malfunction
|
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.H3 other text : the device was not returned.
|
|
Event Description
|
It was reported that the outer packaging of the ureteral stent was marked 6x26, and the size of the contents was 4.7x26.
|
|
Manufacturer Narrative
|
The reported event is confirmed.Visual evaluation noted received 1ureteral stent kit in original closed packaging.Upon unpacking samples it was found in all returned samples that the contained incorrect stent size of 4.7 fr x 26 cm was packaged.Therefore, product does not meet specifications.The root cause is product mix potentially occurred during an incorrectly segregated and returned material process in combination with a poorly performed line release.Labeling review, and dhr review are not required.Correction: d, h 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.H3 other text : the actual/suspected device was inspected.
|
|
Event Description
|
It was reported that the outer packaging of the ureteral stent was marked 6x26, and the size of the contents was 4.7x26.
|
|
Manufacturer Narrative
|
The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be incorrect component.The device was not returned for evaluation.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 review would not 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.H3 other text: the device was not returned.
|
|
Event Description
|
It was reported that the outer packaging of the ureteral stent was marked 6x26, and the size of the contents was 4.7x26.
|
|
Search Alerts/Recalls
|