C.R. BARD, INC. (BASD) -3006260740 MRI POWERPORT ISP; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number UNK MRI POWERPORT ISP |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/14/2024 |
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 return of the sample is pending.However, a photo and an image were provided for review.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.H3 other text : device pending return.
|
|
Event Description
|
It was reported that approximately six months post a port placement, the catheter was allegedly found to be cracked under imaging and pinched off near subclavian area of the patient over routine movement of the patient.It was further reported that the catheter allegedly had leak.Reportedly, the catheter allegedly kinked in the subclavian area.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port and a catheter was returned for evaluation.In addition to the returned physical sample, one electronic photo and image was provided for review.The photo shows a parallel split on the center portion of the catheter.The image depicts the device introduced via a left subclavian venous access and extravasation of infused contrast is seen from an irregular segment of catheter in the midclavicular region.A complete circumferential break was noted to the proximal end of the catheter returned.Catheter wear was observed throughout the center portion of the catheter.Multiple parallel splits were noted on the catheter border approximately 1.2cm, 2.8cm and 11.7cm from the proximal end of the catheter.Upon infusion, leaks were observed from the parallel splits on the catheter.Aspiration was attempted and was unsuccessful.Therefore the investigation is confirmed for the reported fracture, deformation and fluid leak issue.The definitive root cause for the reported event 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 approximately six months post a port placement, the catheter was allegedly found to be cracked under imaging and pinched off near subclavian area of the patient over routine movement of the patient.It was further reported that the catheter allegedly had leak.Reportedly, the catheter allegedly kinked in the subclavian area.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|