BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9586517 · Received January 14, 2020

    Report

    Report Number
    3002682307-2019-00720
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 26, 2019
    Report Date
    February 13, 2020
    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

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301947 LOT 1901202 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE DOSING OF THE PATIENT, THE BARREL WAS FOUND TO BE DAMAGED.

    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 21GA 1-1/2IN BD CHINA EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE DOSING OF THE PATIENT, THE BARREL WAS FOUND TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52518 SYRINGE S2 10ML 21GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other