FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 3-LUMEN 7 FR X 30 CM
MDR report key: 4173600
·
Received August 7, 2014
Report
- Report Number
- 3006425876-2014-00171
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- July 28, 2014
- Report Date
- July 28, 2014
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- FOZ
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT NO. (B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ISSUES WITH CLOTTING. THE USER ALLEGED THAT "THIS EVENT OCCURRED ON SEVERAL ICUS. SOMETIMES THE CATHETER NEEDS TO BE CHANGED. THIS ALSO OCCURRED WITH SINGLE INFUSION. THEREFORE, INFUSION COMPATIBILITY CAN BE EXCLUDED." FOLLOW UP INFORMATION PROVIDED BY THE SENIOR PHYSICIAN STATES THAT "OCCLUSION OF LUMEN WAS NOTED DURING APPLICATION OF SINGLE MEDICATION [FENTANYL] FENTANYL. THE MEDICATION WAS NOT APPLIED WITH A PERFUSOR. EVEN AFTER ASPIRATION AND FLUSHING WITH HEPARINIZED SOLUTION THE LUMEN COULD NOT BE USED ANYMORE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463146 | CVC SET: 3-LUMEN 7 FR X 30 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | FOZ | ARROW INTERNATIONAL INC. | ZF3063440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |