ARROW CANNON II PLUS REPLACEMENT HUB SET
Report
- Report Number
- 9680794-2024-00851
- Event Type
- Malfunction
- Date Received
- September 3, 2024
- Date of Event
- August 12, 2024
- Report Date
- August 13, 2024
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- NFK
- UDI-DI
- 00801902096111
- PMA / PMN Number
- K020430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.
(B)(4).
IT WAS REPORTED "THE DOCTOR FOUND THE LUER HUB DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".
IT WAS REPORTED "THE DOCTOR FOUND THE LUER HUB DAMAGED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699920 | ARROW CANNON II PLUS REPLACEMENT HUB SET | KIT, REPAIR, CATHETER, HEMODI | NFK | ARROW INTERNATIONAL LLC | 33F23C0882 | 00801902096111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NONE REPORTED.| NONE REPORTED. |