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