BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LL BNS

    MDR report key: 8466507 · Received March 29, 2019

    Report

    Report Number
    1911916-2019-00329
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 13, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. IT SHOWS A SYRINGE WITH NO BARREL SCALE, THEREFORE FAILURE MODE IS VERIFIED. THE DEVICE HISTORY RECORD REVIEW DOCUMENTED AN ISSUE OF MISSING PRINT. A BARREL GOT STUCK BETWEEN THE BARREL PREP DIAL AND THE MAIN DIAL. THE BARREL WAS REMOVED AND AFFECTED PARTS WERE REMOVED AND SEGREGATED. THE SAMPLE PROVIDED WAS AN ESCAPE FROM THAT INCIDENT. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR THE LOT # 8023788 FOR THE SAME DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). IT IS DOCUMENTED AN EVENT OF MISSING PRINT; A BARREL GOT STUCK BETWEEN THE BARREL PREP DIAL AND THE MAIN DIAL, THE BARREL WAS REMOVED; AFFECTED PARTS WERE REMOVED AND SEGREGATED. ROOT CAUSE DESCRIPTION: A BARREL GOT STUCK BETWEEN THE BARREL PREP DIAL AND THE MAIN DIAL. THE BARREL WAS REMOVED AND AFFECTED PARTS WERE REMOVED AND SEGREGATED. THE SAMPLE PROVIDED WAS AN ESCAPE FROM THAT INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE LL BNS HAD NO MEASUREMENT LABEL ON IT. CUSTOMER¿S VERBATIM: ¿ THE SYRINGE HAS NO MEASUREMENT PRINT ON IT, IS BLANK.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256194 BD SYRINGE LL BNS SYRINGE FMF BECTON, DICKINSON & CO., (BD) 8023788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other