BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA

    MDR report key: 9498242 · Received December 19, 2019

    Report

    Report Number
    2243072-2019-02866
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    November 28, 2019
    Report Date
    December 31, 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 301947 LOT 1812118 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 LEAKAGE OCCURRED DURING USE WITH A SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT WAS HOSPITALIZED IN OUR HOSPITAL, AND THE SYRINGE WAS USED FOR INTRAVENOUS INFUSION OF PHARMACEUTICAL LIQUID, BUT THE SYRINGE WAS LEAKING AND COULD NOT BE USED, THUS WASTING MEDICAL RESOURCES. THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW SYRINGE, AND THE TREATMENT CONTINUED."

    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 LEAKAGE OCCURRED DURING USE WITH A SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT WAS HOSPITALIZED IN OUR HOSPITAL, AND THE SYRINGE WAS USED FOR INTRAVENOUS INFUSION OF PHARMACEUTICAL LIQUID, BUT THE SYRINGE WAS LEAKING AND COULD NOT BE USED, THUS WASTING MEDICAL RESOURCES. THE PATIENT WAS IMMEDIATELY REPLACED WITH A NEW SYRINGE, AND THE TREATMENT CONTINUED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294482 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other