BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ W/ NEEDLE

    MDR report key: 8658385 · Received May 31, 2019

    Report

    Report Number
    3002682307-2019-00337
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301940 LOT 1803117 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE¿ W/ NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USING, IT WAS FOUND THE SYRINGE LEAKAGE. 2019-05-27 IT WAS FOUND LEAKAGE WHEN THE LIQUID WAS SUCKED.

    Additional Manufacturer Narrative · 1

    HA DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SYRINGE¿ W/ NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USING, IT WAS FOUND THE SYRINGE LEAKAGE. (B)(6) 2019 IT WAS FOUND LEAKAGE WHEN THE LIQUID WAS SUCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454478 BD SYRINGE¿ W/ NEEDLE SYRINGE W/ NEEDLE FMI BECTON DICKINSON, S.A. 1803117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other