C.R. BARD, INC. (BASD) -3006260740 UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number UNK PORT |
Device Problems
Fracture (1260); Device Damaged Prior to Use (2284)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/26/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.The investigation of the reported event is currently underway.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.Device pending return.
|
|
Event Description
|
It was reported that during the preparation of the port placement procedure, the introducer sheath allegedly cracked.The procedure was completed using another device.There was no patient contact.
|
|
Manufacturer Narrative
|
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.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 : device pending return.
|
|
Event Description
|
It was reported that during the preparation of the port placement procedure, the introducer sheath allegedly cracked.The procedure was completed using another device.There was no patient contact.
|
|
Search Alerts/Recalls
|
|
|