FDA Adverse Event
Malfunction
Summary report: N
PED SWAN NCK COIL-CTH P2 LEFT
MDR report key: 2469459
·
Received February 20, 2012
Report
- Report Number
- 1317749-2012-00050
- Event Type
- Malfunction
- Date Received
- February 20, 2012
- Date of Event
- January 10, 2012
- Report Date
- February 9, 2012
- Manufacturer
- ARGYLE (SHERIDAN)
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS (PD) CATHETER. THE CUSTOMER REPORTS A PEDIATRIC PD CATHETER WAS PLACED ON (B)(6) 2012 IN A (B)(6) INFANT. THE CATHETER, POST INSERTION, WAS FOUND TO HAVE TWO LINEAR BREAKS IN INTEGRITY RESULTING IN LEAKAGE OF PERITONEAL FLUID AND REQUIRING REPAIR. THE BREAK WAS NOTED THE DAY AFTER INSERTION AND OCCURRED WHERE THE END ADAPTER TUBING WAS WEAKENED AT THE SITE WHERE IT IS ATTACHED TO THE COVIDIEN TUNNELING DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PED SWAN NCK COIL-CTH P2 LEFT | DIALYSIS CATHETER | FJS | ARGYLE (SHERIDAN) | 8888414813 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 MO |