FDA Adverse Event
Other
Summary report: N
ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)
MDR report key: 1572610
·
Received January 7, 2010
Report
- Report Number
- 9610849-2010-00001
- Event Type
- Other
- Date Received
- January 7, 2010
- Report Date
- December 11, 2009
- Manufacturer
- COVIDIEN
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
COVIDIEN (B)(4) RA REPORTS VIA E-MAIL, CUSTOMER FOUND A HAIR IN THE SYRINGE PRIOR TO USE. NO PT INVOLVED OR HARMED. NO OTHER INFO HAS BEEN MADE AVAILABLE BY CUSTOMER IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ILLUMENA-SYR-W/HF-150ML (LINDEN LUER) | EMPTY DISPOSABLE SYRINGE | DXT | COVIDIEN | 900103 | 9114158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |