FDA Adverse Event
Malfunction
Summary report: N
JACKSON PRATT DRAIN
MDR report key: 2091762
·
Received May 4, 2011
Report
- Report Number
- 2091762
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 21, 2011
- Report Date
- May 4, 2011
- Manufacturer
- CARDINAL
- Product Code
- GCY
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
NURSE ATTEMPTED TO REMOVE A SMALL JP DRAIN FROM THE NECK OF A YOUNG PT. SUTURE CLIPPED, DRAIN PULLED OUT 1 INCH, THEN A SNAP WAS FELT AND THE DRAIN CAME OUT WITH A JAGGED UNEVEN TIP. IT APPEARED NOT ALL THE DRAIN CAME OUT. THE PT WAS SUBSEQUENTLY SCANNED AND RETURNED TO THE OR THE NEXT DAY TO RETRIEVE THE REMAINING PORTION OF THE DRAIN. UNFORTUNATELY, THE END PIECE WAS NOT RETAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JACKSON PRATT DRAIN | JACKSON PRATT DRAIN | GCY | CARDINAL | RD 7FR END PERF | POSSIBLE 1090478 OR 1090950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |