C.R. BARD, INC. (BASD) -3006260740 LOW ARTIFACT POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number UNK LOW ARTIFACT POWER PORT |
Device Problems
Disconnection (1171); Malposition of Device (2616); Migration (4003)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/07/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
|
|
Event Description
|
It was reported that approximately one month post port placement procedure, the catheter was identified allegedly out of position after the port was check under imaging with contrast.It was further reported that tip of the catheter was allegedly butt to the vessel wall at the junction of the azygous vein.Reportedly, the port was removed and replaced.The current status of the patient is stable.
|
|
Event Description
|
It was reported that approximately one month post port placement procedure, the catheter was identified allegedly out of position after the port was check under imaging with contrast.It was further reported that tip of the catheter was allegedly butt to the vessel wall at the junction of the azygous vein.Reportedly, the port was removed and replaced.There was no reported patient injury.
|
|
Manufacturer Narrative
|
Additional information was received and the file was reassessed for reportability and determined to be reportable as malfunction.Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one clearvue implantable port with a catheter attached was returned for evaluation.Gross, microscopic visual and functional testing were performed.A complete circumferential break was noted on the distal end of the catheter.Under microscopic observation, the edges of the complete circumferential break on the distal end appeared to be uneven and striations were noted throughout.Therefore, the investigation is inconclusive for the reported failure as the exact circumstances at the time of reported event cannot be verified.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 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.
|
|
Search Alerts/Recalls
|
|
|