FDA Adverse Event
Malfunction
Summary report: N
CASE-150ML SYRINGE WITH HANDIFIL
MDR report key: 1051364
·
Received May 16, 2008
Report
- Report Number
- 9610849-2008-00022
- Event Type
- Malfunction
- Date Received
- May 16, 2008
- Report Date
- November 14, 2005
- Manufacturer
- COVIDIEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HISTORY RECORD: DUE TO LOT NUMBER NOT BEING PROVIDED BY THE CUSTOMER, IT IS NOT POSSIBLE TO GET THE HISTORY RECORD OF THE 150ML SYRINGE WITH HANDIFIL. PROCESS: THE ASSEMBLY PROCESS OF SYRINGES P/N 600269 IS PERFORMED IN ACCORDANCE TO INTERNAL PROCEDURE: LF POUCHING OPERATION. EVALUATION: NO SAMPLE AND/OR LOT NUMBER WAS RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
YUFU REPORTS: CUSTOMER STATES THAT A WHITE THIN FOREIGN OBJECT WAS ATTACHED TO THE BLUE LUER NUT. WHEN THE PHYSICIAN INTRODUCED CONTRAST INTO THE SYRINGE HALF WAY, A WHITE THREAD STATED DUST WAS FOUND ON THE LUER NUT TIP AND HE STOPPED THE EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CASE-150ML SYRINGE WITH HANDIFIL | DISPOSABLE SYRINGE, EMPTY | DXT | COVIDIEN | 600269 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |