ARROW CANNON II PLUS REPLACEMENT HUB SET
Report
- Report Number
- 1036844-2017-00455
- Event Type
- Malfunction
- Date Received
- December 27, 2017
- Date of Event
- December 12, 2017
- Report Date
- December 13, 2017
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- NFK
- PMA / PMN Number
- K020430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON THE SALES HISTORY OF THE CUSTOMER. 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.
THE CUSTOMER REPORTS THAT A PATIENT HAD A PEMCATH INSERTED 2 MONTHS AGO, AND A WEEK AGO PRESENTED WITH A CRACKED HUB ON ONE OF THE LUMEN, THEY CHANGED THE HUB AND INSERTED CAR02400, SHE HAS NOW RETURNED WITH THE HUB LEAKING (DOCUMENTED IN MDR# 1036844-2017-00456).
THE CUSTOMER REPORTS THAT A PATIENT HAD A PEMCATH INSERTED 2 MONTHS AGO, AND A WEEK AGO PRESENTED WITH A CRACKED HUB ON ONE OF THE LUMEN, THEY CHANGED THE HUB AND INSERTED CAR02400, SHE HAS NOW RETURNED WITH THE HUB LEAKING (DOCUMENTED IN MDR# 1036844-2017-00456).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 927385 | ARROW CANNON II PLUS REPLACEMENT HUB SET | KIT, REPAIR, CATHETER, HEMODI | NFK | ARROW INTERNATIONAL INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |