FDA Adverse Event
Malfunction
Summary report: N
EPIDURAL CATHETERIZATION KIT
MDR report key: 2243886
·
Received August 24, 2011
Report
- Report Number
- 1036844-2011-00282
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 12, 2011
- Report Date
- August 23, 2011
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- CAZ
- PMA / PMN Number
- K884552
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE KIT WAS OPENED, ALL OF THE AMPULES WERE FOUND BROKEN IN THE TRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIDURAL CATHETERIZATION KIT | ANESTHESIA PRODUCTS | CAZ | ARROW INTERNATIONAL INC. | RF1045425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |