FDA Adverse Event
Malfunction
Summary report: N
8030665-2003-00118
MDR report key: 490626
·
Received September 24, 2003
Report
- Report Number
- 8030665-2003-00118
- Event Type
- Malfunction
- Date Received
- September 24, 2003
- Date of Event
- August 12, 2003
- Report Date
- September 24, 2003
- Manufacturer
- REYNOSA MFG
- Product Code
- FJK
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
Narratives
Description of Event or Problem · 1
FACILITY REPORTED THAT DURING PRIMING OF THE COMBI SET THE TECH NOTED SALINE LEAKING. UPON CLOSER EXAMINATION THE TECH FOUND THE EXTRA ADMINISTRATAION LINE WAS ALMOST COMPLETELY DISCONNECTED AT THE GLUE JOINT. REPORTEDLY, THE SAME PROBLEM HAD BEEN NOTED WITH THIS PRODUCT ON ONE PRIOR OCCASION. IN SPEAKING WITH THE INITIAL REPORTER FROM THE DIALYSIS FACILITY SHE BELIEVES THAT THE SAMPLE HAS ALREADY BEEN RETURNED TO REYNOSA FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FJK | REYNOSA MFG | NA | 3ER203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |