BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL

    MDR report key: 10910018 · Received November 26, 2020

    Report

    Report Number
    1213809-2020-00845
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 2, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION? YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: FOUR PHOTOS DISPLAYING A TOTAL OF THIRTEEN OF 3ML SYRINGES IN FULLY SEALED BLISTER PACKS (P/N 309657) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ONE OF THE SYRINGES HAD THE BATCH NUMBER 5300809 EMBOSSED ON THE PEEL TAB. TWELVE OF THE PACKAGES HAD THE BATCH NUMBER 6110527 PRINTED ON THE PEEL TAB. NO DEFECTS WERE OBSERVED. BATCH 5300809 WAS MANUFACTURED IN 2015, PRIOR TO THE UDI REQUIREMENTS THAT MANDATED MARKING INDIVIDUAL PACKAGING WITH EXPIRATION DATE. BATCH 5300809 WAS MANUFACTURED CORRECTLY PER PRODUCT DESIGN AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABEL WAS MISSING THE LOT AND AND EXPIRATION DATE WITH A BD SYRINGE 3ML LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT EXPIRATION AND LOT NUMBER WERE MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABEL WAS MISSING THE LOT, AND EXPIRATION DATE WITH A BD SYRINGE 3ML LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT EXPIRATION AND LOT NUMBER WERE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376780 BD SYRINGE 3ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 5300809 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1