BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 9316253 · Received November 13, 2019

    Report

    Report Number
    3002682307-2019-00606
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    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 301942 LOT 1811193 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 A "RUPTURE" WAS NOTICED IN THE BD¿ SYRINGE BEFORE USE WHEN GIVING THE PATIENT A "NEBULIZER". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE NURSE NOTICED A RUPTURE IN THE SYRINGE WHEN SHE WAS GIVING THE PATIENT THE NEBULIZER".

    Additional Manufacturer Narrative · 1

    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 A "RUPTURE" WAS NOTICED IN THE BD¿ SYRINGE BEFORE USE WHEN GIVING THE PATIENT A "NEBULIZER". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE NURSE NOTICED A RUPTURE IN THE SYRINGE WHEN SHE WAS GIVING THE PATIENT THE NEBULIZER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108306 BD SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other