BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T U100 25G 1IN

    MDR report key: 10131364 · Received June 8, 2020

    Report

    Report Number
    1213809-2020-00378
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. BATCH 5141874 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE COMPLAINT IS FOR A BATCH THAT WAS MANUFACTURED IN JUN 2015. BATCH 5141874 WAS MANUFACTURED AND LABELED IN ACCORDANCE WITH PROPER STANDARDS AND REQUIREMENTS AT THAT TIME. THERE WAS NO REQUIREMENT TO HAVE EXPIRATION DATE PRINTED ON THE PACKAGES. BATCH 5141874 EXPIRED 5 YEARS AFTER THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML S/T U100 25G 1IN EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACY REPORTED--ITEM # 329622 LOT # 5141874 WITHOUT EXP DATE INFO. FOUND ITEMS WITHIN OLD STOCK. ADVISED PHARMACY THIS IS DISCONTINUED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1ML S/T U100 25G 1IN EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACY REPORTED ITEM # 329622 LOT # 5141874 WITHOUT EXP DATE INFO. FOUND ITEMS WITHIN OLD STOCK. ADVISED PHARMACY THIS IS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595409 SYRINGE 1ML S/T U100 25G 1IN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5141874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other