FDA Adverse Event
Malfunction
Summary report: N
BECTON, DICKINSON AND CO
MDR report key: 511121
·
Received January 30, 2004
Report
- Report Number
- MW1031025
- Event Type
- Malfunction
- Date Received
- January 30, 2004
- Report Date
- January 30, 2004
- Manufacturer
- *
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UT, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D MFR 5/20/2004: BD MEDICAL SURGICAL QA AND RA HAS EVALUATED REPORT AND SAMPLE. SINCE NO ACTUAL SAMPLES WHICH DISPLAY THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, MFR IS UNABLE TO FULLY INVESTIGATE THIS INCIDENT. MFR NEEDS TO SEE THE ACTUAL SAMPLE TO DETERMINE WHAT THE FOREIGN MATTER IS AND WHAT THE POSSIBLE CAUSES ARE. THE MANUFACTURING FACILITY HAS BEEN ADVISED OF THIS REPORT. MFR REGRETS ANY INCONVENIENCE THAT MAY HAVE RESULTED FORM THIS INCIDENT.
Description of Event or Problem · 1
THE BD 10ML LUER-LOK TIP SYRINGE BARCODE= -01-00382903096046, REF= 309604, HAS A SUSPICIOUS BROWN SUBSTANCE IN THE SYRINGE STILL SEALED IN THE PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BECTON, DICKINSON AND CO | 10ML DISPOSABLE SYRINGE | FMF | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |