C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 05/15/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.Based on a review of this information, the following was concluded: the complaint that the needle detached from the housing was confirmed and the root cause appeared to be manufacturing related.One 18g powerglide deployment system was provided for investigation.The needle had fully separated from the green needle hub that was positioned within the handle.A microscopic examination of the green needle hub revealed a small trace of what appeared to be adhesive within the bore of the needle hub.No adhesive was observed on the external surface of the needle hub or on the needle shaft.One factor of the separation of the needle from the green needle hub appeared to be related to the poor bonding between the needle and hub.Bd is working closely with the supplier/manufacturing to prevent recurrence of the reported event.A quality alert was issued at the manufacturing site.
|
|
Event Description
|
A powerglide was returned for evaluation without a reported complaint.Initial observation revealed this device has the needle detached from the housing and the guidewire is still inside holding the two pieces together.11/29/2023 - during evaluation, the needle was found to have fully separated from the green needle hub within the handle.
|
|
Search Alerts/Recalls
|
|
|