FDA Adverse Event
Malfunction
Summary report: N
15.5F X 32CM DURA-FLOW
MDR report key: 1920971
·
Received November 11, 2010
Report
- Report Number
- 2518902-2010-00071
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- September 21, 2010
- Report Date
- November 12, 2010
- Manufacturer
- MEDCOMP
- Product Code
- MSD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE DIALYSIS CATHETER EXCHANGE THE CATHETER BALLOONED OUT. NO HARM TO THE PT. THEY EXCHANGED THE CATHETER FOR A NEW ONE. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 15.5F X 32CM DURA-FLOW | HEMODIALYSIS CATHETER | MSD | MEDCOMP | 10301203 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |