FDA Adverse Event
Other
Summary report: N
LUER LOK TIP 60 ML SYRINGE
MDR report key: 6144370
·
Received December 2, 2016
Report
- Report Number
- MW5066487
- Event Type
- Other
- Date Received
- December 2, 2016
- Report Date
- September 23, 2016
- Manufacturer
- BECTON DICKINSON & CO.
- Product Code
- FMF
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DESCRIPTION: THE CHEMOTHERAPY TECH WAS WITHDRAWING RITUXAN FROM THE VIAL INTO A BD-60 ML LUER LOK TIP SYRINGE LOT #6182677, EXP 06/2021. THE RITUXAN LEAKED AROUND THE BLACK PLUNGER STOPPER. THE TECH HAD TO DISCARD THE TREATMENT AND REMAKE DUE TO THE LEAKAGE AND POSSIBLE CONTAMINATION. MEDICATION ADMINISTERED TO OR USED BY THE PT. OUTCOME: THE TECH HAD TO DISCARD THE TREATMENT AND REMAKE DUE TO THE LEAKAGE AND POSSIBLE CONTAMINATION. PT COUNSELING PROVIDED: UNK. SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 793971 | LUER LOK TIP 60 ML SYRINGE | LUER LOK TIP 60 ML SYRINGE | FMF | BECTON DICKINSON & CO. | 6182677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |