FDA Adverse Event
Injury
Summary report: N
MALLEABLE CATHETER PASSER, ONG
MDR report key: 539150
·
Received August 13, 2004
Report
- Report Number
- 1226348-2004-00253
- Event Type
- Injury
- Date Received
- August 13, 2004
- Date of Event
- July 14, 2004
- Report Date
- July 15, 2004
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- KGZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTS THAT DURING VP SHUNT INSERTION, THE CATHETER PASSER BROKE IN THE PT'S NECK WHEN BEING PASSED UNDER THE SKIN. THE SURGEON WAS UNABLE TO LOCATE THE BROKEN PIECE. THE BROKEN PIECE WAS NOT PALPABLE. THE PT IS REPORTED TO BE IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLEABLE CATHETER PASSER, ONG | ACCESSORIES, CATHETER | KGZ | CODMAN & SHURTLEFF, INC. | NA | HV248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |