FDA Adverse Event
Malfunction
Summary report: N
SWAN NECK COIL CATH CA2 LEFT
MDR report key: 1781357
·
Received July 29, 2010
Report
- Report Number
- 1317749-2010-00207
- Event Type
- Malfunction
- Date Received
- July 29, 2010
- Date of Event
- May 26, 2010
- Report Date
- July 9, 2010
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER REPORTS THE PATIENT DEVELOPED A HOLE IN THE SILICONE TUBING, AT THE END OF THE ADAPTER. CATHETER WAS PLACED 6/16/09, AND TRANSFER SET AND ADAPTER CHANGED ON (B)(6) 2010. PATIENT REQUIRED PROPHYLACTIC ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN NECK COIL CATH CA2 LEFT | PERITONEAL DIALYSIS CATHETER | MSD | COVIDIEN | 8888413807 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |