C.R. BARD, INC. (BASD) -3006260740 POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 1708000 |
Device Problems
Fracture (1260); Device Appears to Trigger Rejection (1524); Suction Problem (2170)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/29/2021 |
Event Type
Injury
|
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.H3 other text : device not returned.
|
|
Event Description
|
It was reported that sometime post a port placement, the catheter was allegedly fractured.There was no reported patient injury.
|
|
Event Description
|
It was reported through the litigation process that sometime post a port placement, the catheter was allegedly fractured.It was further reported that the blood was allegedly unable to be aspirated.Furthermore, patient allegedly experienced fibrin sheath formation around the tip of the catheter.Reportedly, the port was removed and replaced.The current status of the patient is unknown.
|
|
Manufacturer Narrative
|
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.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 not returned.
|
|
Search Alerts/Recalls
|
|
|