BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 20 ML SYRINGE

    MDR report key: 9354788 · Received November 21, 2019

    Report

    Report Number
    3002682307-2019-00614
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    August 6, 2019
    Report Date
    December 18, 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
    GM
    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 300296 LOT 1902139 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD DISCARDIT¿ II 20 ML SYRINGE THERE WAS AN ISSUE WITH LEAKAGE THROUGH THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THERE WAS A LEAK AGAIN DURING EXTRACTION. SALINE LEAKS (PASSES) THROUGH 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 DURING USE OF THE BD DISCARDIT¿ II 20 ML SYRINGE THERE WAS AN ISSUE WITH LEAKAGE THROUGH THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THERE WAS A LEAK AGAIN DURING EXTRACTION. SALINE LEAKS (PASSES) THROUGH THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154220 BD DISCARDIT II 20 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1902139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other