ARROW CVC SET: 16 GA X 8" (20 CM)
Report
- Report Number
- 3006425876-2022-00814
- Event Type
- Malfunction
- Date Received
- September 21, 2022
- Date of Event
- August 24, 2022
- Report Date
- August 26, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH TWO RELEVANT FINDINGS. FOR MATERIAL K-04300-019A AND LOT 71P21B0956, TWO NON-CONFORMANCES WERE INITIATED RELATED TO SYRINGE/NEEDLE CONNECTION NOT SECURE. 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.
IT WAS REPORTED THE ARROW RAULERSON SYRINGE (ARS) WAS FOUND LEAKING DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
IT WAS REPORTED THE ARROW RAULERSON SYRINGE (ARS) WAS FOUND LEAKING DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553174 | ARROW CVC SET: 16 GA X 8" (20 CM) | CATHETER PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | 71F21E1162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |