BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE LL EUROGRAPHICS

    MDR report key: 8214989 · Received January 3, 2019

    Report

    Report Number
    1213809-2018-00959
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 17, 2018
    Report Date
    April 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ELEVEN 10ML LL SYRINGES IN ORIGINAL PACKAGING WITH SEALS INTACT FROM BATCH #8213899 (P/N 300912) WERE RECEIVED. A VISUAL INSPECTION WAS PERFORMED, AND NO ASSEMBLY DEFECTS WERE OBSERVED. ALL SAMPLES WERE TESTED BY EXERCISING THE PLUNGER OF EACH SYRINGE TO THE NOMINAL CAPACITY AND BACK TO ZERO LINE MULTIPLE TIMES. NO DEFECTS WERE OBSERVED. THE MOVEMENT WAS SMOOTH AND UNINTERRUPTED AND PLUNGER ROD REMAINED ATTACHED TO THE STOPPER. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN THE SAMPLES RECEIVED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE LL EUROGRAPHICS HAD SEPARATION OF STOPPER FROM PLUNGER DURING USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 BD¿ SYRINGE LL EUROGRAPHICS HAD SEPARATION OF STOPPER FROM PLUNGER DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4509 BD¿ SYRINGE LL EUROGRAPHICS GENERAL-PURPOSE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8123899 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other