ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM
Report
- Report Number
- 3006425876-2023-00931
- Event Type
- Malfunction
- Date Received
- September 26, 2023
- Date of Event
- August 30, 2023
- Report Date
- August 31, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- FOZ
- PMA / PMN Number
- K970864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
(B)(4).
IT WAS REPORTED THAT THE USER WAS UNABLE TO OCCLUDE THE BLOOD REMOVAL LUMEN WITH THE RED PINCH CLAMP DURING USE. HOWEVER, THE USER DECIDED THAT THE CATHETER COULD BE USED EVEN IF THE CLAMP DID NOT WORK, AND PLACED THE CATHETER TO THE PATIENT AS IT WAS. NO INJURY TO THE PATIENT OCCURRED. THE PATIENT IS RECEIVING INTRAVENOUS FLUIDS THROUGH THAT LINE WITHOUT PINCH CLAMP.
IT WAS REPORTED THAT THE USER WAS UNABLE TO OCCLUDE THE BLOOD REMOVAL LUMEN WITH THE RED PINCH CLAMP DURING USE. HOWEVER, THE USER DECIDED THAT THE CATHETER COULD BE USED EVEN IF THE CLAMP DID NOT WORK, AND PLACED THE CATHETER TO THE PATIENT AS IT WAS. NO INJURY TO THE PATIENT OCCURRED. THE PATIENT IS RECEIVING INTRAVENOUS FLUIDS THROUGH THAT LINE WITHOUT PINCH CLAMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 973600 | ARROW CVC KIT: 3-LUMEN 12 FR X 20 CM | CATHETER INTRAVASCULAR THERAPE | FOZ | ARROW INTERNATIONAL LLC | 71F22F3476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | NOT REPORTED| NOT REPORTED |