BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA

    MDR report key: 8508826 · Received April 12, 2019

    Report

    Report Number
    3002682307-2019-00248
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 21, 2019
    Report Date
    June 5, 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 PHOTOS OR SAMPLES FOR CATALOG 301945 LOT 1811101 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 THE SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE FOUND THAT SYRINGE LEAKAGE DURING USING.

    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 THE SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE FOUND THAT SYRINGE LEAKAGE DURING USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300638 SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other