FDA Adverse Event
Malfunction
Summary report: N
STIMM CATH 19 GA 60 CM ARROW REF
MDR report key: 2935569
·
Received January 23, 2013
Report
- Report Number
- MW5028774
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 23, 2013
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- CAZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CONTINUOUS NERVE BLOCK CATHETER HAD A HOLE IN IT AND MEDICATION WAS LEAKING FROM THE SITE OF THE HOLE. CATHETER REMOVED NO ADVERSE EFFECT TO THE PATIENT. REASON FOR USE: NERVE BLOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33206 | STIMM CATH 19 GA 60 CM ARROW REF | CONTINUOUS NERVE BLOCK | CAZ | ARROW INTERNATIONAL, INC. | RF2108521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |