FDA Adverse Event
Malfunction
Summary report: N
CURL CATH 62CM 2 CUFF
MDR report key: 2024049
·
Received March 14, 2011
Report
- Report Number
- 1317749-2011-00088
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- January 12, 2011
- Report Date
- February 28, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2011. 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) 2011, THAT A CUSTOMER HAD AN ISSUE WITH AS PERITONEAL DIALYSIS CATHETER. THE CUSTOMER STATES THE PATIENT FIRST USED THE CATHETER ON (B)(6) 2009 AND THE DOCTOR FOUND A CRACK IN THE TUBING OF THE CATHETER ON (B)(6) 2011. THE CATHETER WAS REMOVED AND REPLACED, AND PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURL CATH 62CM 2 CUFF | PERITONEAL DIALYSIS CATHETER | FJS | COVIDIEN | 8811313010 | 900734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |