FDA Adverse Event
Malfunction
Summary report: N
BD 50ML LUER-LOK SYRINGE
MDR report key: 20676193
·
Received November 12, 2024
Report
- Report Number
- MW5162439
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- November 7, 2024
- Report Date
- November 7, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WE RECEIVED 50ML LUER-LOK SYRINGES WHICH DEMONSTRATE POOR QUALITY CONTROL DURING MANUFACTURE. NUMEROUS SYRINGES CAME FROM THE MANUFACTURER WITH INCOMPLETE GRADUATION MARKS, OR ENTIRELY WITHOUT GRADUATION MARKS. ALL HAD THE FOLLOWING IDENTIFIERS REF: 30965, LOT: 4080219, EXP: 2029-03-31, BARCODE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1168366 | BD 50ML LUER-LOK SYRINGE | SYRINGE, PISTON | FMF | BECTON, DICKINSON AND COMPANY | 30965 | 4080219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |