C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 8808060 |
Device Problems
Defective Component (2292); Deformation Due to Compressive Stress (2889)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/23/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
As the lot number for the device was provided, a review of the device history records was 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.(expiry date: 05/2023).
|
|
Event Description
|
It was reported that during a port placement procedure, the peel away sheath was allegedly defective.The procedure was completed by using another device.There was no reported patient injury.
|
|
Event Description
|
It was reported that during a port placement procedure, the peel away sheath was allegedly wrinkled.The procedure was completed by using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 05/2023).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
|
|
|