FDA Adverse Event
Malfunction
Summary report: N
16FR ULTRAMER (LTX) DRAIN BAG F
MDR report key: 2102580
·
Received May 20, 2011
Report
- Report Number
- 9612030-2011-00006
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- March 28, 2011
- Report Date
- May 5, 2011
- Manufacturer
- COVIDIEN
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- 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 A URINARY CATHETER. THE CUSTOMER STATES THE CATHETER FAILED TO DEFLATE. THE CUSTOMER STATES THE CATHETER WAS EXPELLED DURING CHILD BIRTH AND THERE WAS NO MEDICAL INTERVENTION OR HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 16FR ULTRAMER (LTX) DRAIN BAG F | URINARY CATHETER | KOD | COVIDIEN | 6165LL | 031952064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |