C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 1808060 |
Device Problems
Material Discolored (1170); Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/25/2023 |
Event Type
malfunction
|
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 sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 one year three month and fourteen days post port placement, the catheter tubing was allegedly found to be discolored upon removal from the patient.It was further reported that the tubing was allegedly found to be fractured.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: manufacturing review: a device history record/batch history record review was not requested as the reported lot number is unknown.Investigation summary: one powerport implantable port attached to a catheter was returned for evaluation.Gross visual, microscopic and functional evaluation were performed.During visual evaluation, the sample appeared to have discoloration throughout, and a longitudinal split was noted approximately 7.6cm from the distal end of the cath-lock.Upon infusion, dye water was observed exiting the longitudinal split in the catheter while water exited the distal end.Aspiration was attempted and was unsuccessful as the dye water did not fully return to the in-house syringe.Therefore, the investigation is confirmed for the reported material discoloration and fracture issues.The definitive root cause could not be determined based upon available 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.
|
|
Event Description
|
It was reported that one year three month and fourteen days post port placement, the catheter tubing was allegedly found to be discolored upon removal from the patient.It was further reported that the tubing was allegedly found to be fractured.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|