C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Component Missing (2306)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/22/2022 |
Event Type
malfunction
|
Event Description
|
It was reported by the customer that "the kit, when opened, the access needle was laying outside of the tray with no captor safety putting the clinician as well as their tech at risk for a needle stick".
|
|
Manufacturer Narrative
|
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regx1017 showed no other similar product complaint(s) from this lot number.
|
|
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.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached needle cover is inconclusive due to poor sample condition.One photo sample of an open catheter kit tray and components was provided.A photo of the product label indicating lot: regx1017 was also provided.The photo showed the blue drapes folded over the open kit tray.A scalpel is besides the kit tray.The 21 ga introducer needle is shown near the proximal end of the scalpel handle without the plastic needle cover.The safety mechanism has not been activated.The needle cover was observed to be located near the distal end of the scalpel.The condition of the components prior to kit handling and opening is unknown.Based on the information provided, possible contributing factors include movement of components within packaging prior to or after handling.Since the condition of the components prior to kit opening and handling is unknown, the complaint could not be confirmed and remains inconclusive at this time.H3 other text : evaluation findings are in section h.11.
|
|
Event Description
|
It was reported by the customer that "the kit, when opened, the access needle was laying outside of the tray with no captor safety putting the clinician as well as their tech at risk for a needle stick.".
|
|
Search Alerts/Recalls
|
|
|