C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number UNKNOWN POWER PORT |
Device Problems
Break (1069); Expulsion (2933)
|
Patient Problems
Skin Erosion (2075); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/26/2023 |
Event Type
Injury
|
Event Description
|
It was reported that sometimes post a port placement, sutures were allegedly found to be sticking out of the skin.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.
|
|
Manufacturer Narrative
|
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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 : device not returned.
|
|
Event Description
|
It was reported that sometimes post a port placement, patient allegedly experienced a small break in the skin and felt like the port was starting to break through the skin.It was further reported that sutures were allegedly found to be sticking out of the skin.The current status of the patient was unknown.
|
|
Search Alerts/Recalls
|
|
|