FDA Adverse Event
Malfunction
Summary report: N
DOUBLE T-CONNECTOR WITH 4 INCH EXTENSION SET
MDR report key: 485746
·
Received September 18, 2003
Report
- Report Number
- 1526863-2003-00090
- Event Type
- Malfunction
- Date Received
- September 18, 2003
- Report Date
- August 28, 2003
- Manufacturer
- MEDEX
- Product Code
- FKB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT THE MALE LUER BROKE OFF WHEN TRYING TO CONNECT. NO PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DOUBLE T-CONNECTOR WITH 4 INCH EXTENSION SET | T-CONNECTOR | FKB | MEDEX | NA | 33D070097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |