BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE 10ML LL TIP

    MDR report key: 9597205 · Received January 16, 2020

    Report

    Report Number
    1213809-2020-00007
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 3, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: ACTUAL LOT NUMBER IS UNKNOWN, HOWEVER THE CUSTOMER SUSPECTS LOTS 9066747 (MFR: 2019-03-07 & EXP: 2024-02-29) OR 9092593 (MFR: 2019-04-02 & EXP: 2024-03-31). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 10ML LL TIP HAS BEEN FOUND EXPERIENCING STERILITY ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309605 BATCH NO.: UNKNOWN BUT POSSIBLY( 9066747 OR 9092593). IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE LIP OF A SYRINGE TRAY FROM LOT 9066747 OR LOT 9092593. IT HAS SINCE MOVED FROM THE LOCATION BUT THEY STILL HAVE IT IN THE BAG TO BE RETURNED. PER EMAIL: A HAIR WAS FOUND INSIDE THE LIP OF A SYRINGE TRAY FROM LOT 9066747 OR LOT 9092593.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62423 BD¿ SYRINGE 10ML LL TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other