C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number UNKNOWN POWER PORT |
Device Problem
Expulsion (2933)
|
Patient Problems
Skin Erosion (2075); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/15/2022 |
Event Type
Injury
|
Event Description
|
It was reported that post port device implant, the patient allegedly experienced skin erosion.The current status of the patient is unknown.
|
|
Manufacturer Narrative
|
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.
|
|
Manufacturer Narrative
|
H10: additional information was received and the file was reassessed for reportability and determined to be reportable as a malfunction.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H11:section a through f - the information provided by bd represents all of 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 post port device implant, the patient allegedly experienced skin erosion.No medication was administered to the patient.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: additional information was received and the reportability was reassessed as serious injury.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one unknown power port was implanted to the patient chest region.All the three bumps were noted to be expulsed over the patient skin.Redness was observed on the region around the port body.Therefore, the investigation is inconclusive for the reported skin erosion as the issue occurred in the clinical conditions cannot be confirmed based on the provided photo.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provide 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 post port device implant, the patient allegedly experienced skin erosion.The current status of the patient is unknown.
|
|
Search Alerts/Recalls
|
|
|