FDA Adverse Event
Malfunction
Summary report: N
PED SWN NCK CRL CTH 42.9CM 2CM
MDR report key: 1493123
·
Received August 19, 2009
Report
- Report Number
- 1317749-2009-00209
- Event Type
- Malfunction
- Date Received
- August 19, 2009
- Report Date
- July 24, 2009
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THE ADAPTER FELL OUT OF THE PATIENT'S CATHETER; THE PARENTS OF THE PATIENT RE-CONNECTED THE ADAPTER TO THE CATHETER. PATIENT DEVELOPED PERITONITIS AND REQUIRED ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PED SWN NCK CRL CTH 42.9CM 2CM | PERITONEAL DIALYSIS CATHETER | FJS | COVIDIEN | 888413101 | 801124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |