FDA Adverse Event
Malfunction
Summary report: N
LUER LOCK
MDR report key: 5161777
·
Received October 12, 2015
Report
- Report Number
- MW5057210
- Event Type
- Malfunction
- Date Received
- October 12, 2015
- Date of Event
- October 12, 2015
- Report Date
- October 12, 2015
- Manufacturer
- BD
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
FOUND BROWN MARKS (DIRT?) ON OUTSIDE OF STERILE SYRINGE WHILE IN PACKAGING FOR BD 60ML LUER LOCK SYRINGE LOT #5162782 EXP 6-2020. REPORTING HERE AS WELL AS LEFT MESSAGE WITH PRODUCT COMPLAINT LINE AT MANUFACTURER. REASON FOR USE: USE TO DRAW UP STERILE MEDICATIONS FOR IV PREPARATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675153 | LUER LOCK | SYRINGE | FMF | BD | 5162782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |