FDA Adverse Event
Malfunction
Summary report: N
CONTINUOUS PERIPHERAL NE RVE BLOCK KIT; 2
MDR report key: 3021023
·
Received March 20, 2013
Report
- Report Number
- 2242445-2013-00035
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 19, 2013
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- CAZ
- PMA / PMN Number
- K030937
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED TO THE SALES REP DURING AN IN-SERVICE THAT THERE WAS A SAMPLE SAVED OF A CATHETER WHERE THE METAL COIL STRETCHED AND IS LONGER THAN NORMAL. THERE ARE NO DETAILS AVAILABLE FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116260 | CONTINUOUS PERIPHERAL NE RVE BLOCK KIT; 2 | ANESTHESIA PRODUCTS | CAZ | ARROW INTERNATIONAL INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |