BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 8504555 · Received April 11, 2019

    Report

    Report Number
    3002682307-2019-00245
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 28, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS NOT PROVIDED PHOTOS OR SAMPLES FOR CATALOG 309050 LOT 1810158 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 FROM THE BD DISCARDIT¿ II SYRINGE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ISSUE RELATED TO THE SYRINGE OF 5 ML: LEAKAGE AT THE PLUNGER."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 FROM THE BD DISCARDIT¿ II SYRINGE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ISSUE RELATED TO THE SYRINGE OF 5 ML: LEAKAGE AT THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300229 BD DISCARDIT II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1810158

    Patients

    Seq Age Sex Outcome Treatment
    1 Other