C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 7707540J |
Device Problems
Degraded (1153); Fracture (1260); Peeled/Delaminated (1454)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/06/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The catalog number identified has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f are identified.As the lot number for the device was not provided, a review of the device history records 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 eleven years and two months post port implant, the catheter allegedly found to be damaged approximately three cm distal to the port stem.It was further reported that deterioration was seen on the catheter.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one x-port isp implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed on the returned device.The investigation is confirmed for the identified degraded and peeled issues as the catheter was noted to be degraded from the 11.0cm depth mark to the distal end of the cath-lock and the catheter material appeared to be peeled off in the same region.However, the investigation is unconfirmed for the reported fracture issue as no evidence relating fracture were noted on the returned device.The definitive root cause could not be determined based upon 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.H3 other text : see h10.
|
|
Event Description
|
It was reported that approximately eleven years and two months post port implant, the catheter allegedly found to be damaged approximately three cm distal to the port stem.It was further reported that deterioration was seen on the catheter.The device was removed from the patient.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|