C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 5608062 |
Device Problems
Fluid/Blood Leak (1250); Expulsion (2933)
|
Patient Problems
Erythema (1840); Skin Erosion (2075)
|
Event Date 07/31/2023 |
Event Type
Injury
|
Event Description
|
It was reported that three weeks and five days post port placement, the patient allegedly experienced erythema.It was further reported that fluid allegedly leaked from the lateral port pocket site through a potential small opening in the skin.Furthermore, the patient allegedly had redness and potential skin erosion.Reportedly, the port was removed.The current status of the patient is unknown.
|
|
Manufacturer Narrative
|
H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiration date: 10/2024).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.
|
|
Search Alerts/Recalls
|
|
|