C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number UNKNOWN POWER PORT |
Device Problems
Blocked Connection (2888); Device Markings/Labelling Problem (2911)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/28/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that sometime post port placement, upon an x-ray examination, the port allegedly did not showed the port identifiers in the x-ray image.There was no reported patient 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 return of the sample is pending.However, a photo and images were provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide 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 pending return.
|
|
Event Description
|
It was reported that sometimes post a port placement, the port was allegedly unable to accessed.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.H11: the initial mdr was inadvertently submitted with a g3 date of 10/02/2023.The correct g3 date is 10/11/2023.H11: section a through f ¿ the information provide 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 pending return.
|
|
Search Alerts/Recalls
|
|
|