BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 20 ML SYRINGE

    MDR report key: 9257796 · Received October 30, 2019

    Report

    Report Number
    3002682307-2019-00580
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 7, 2019
    Report Date
    November 27, 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

    INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 300296 LOT 1905240 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 BD DISCARDIT¿ II 20 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE INDUCTION OF ANESTHESIA IT HAS BEEN NOTICED THAT PART OF THE ANESTHETIC HAS PUSHED PAST THE PLUNGER UPWARDS IN THE SYRINGE. AS A RESULT, IT CAN NOT BE DETERMINED WITH CERTAINTY HOW MUCH ANESTHETIC WAS ADMINISTERED AND HOW MUCH WAS LOST. A CLOSER EXAMINATION OF THE SYRINGE AND REFILLING WITH NACL SHOWED THAT THE PLUNGER DEFECT IS AND LIQUID IS LOST TO THE TOP. THIS HAS HAPPENED SEVERAL TIMES NOW."

    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 BD DISCARDIT¿ II 20 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE INDUCTION OF ANESTHESIA IT HAS BEEN NOTICED THAT PART OF THE ANESTHETIC HAS PUSHED PAST THE PLUNGER UPWARDS IN THE SYRINGE. AS A RESULT, IT CAN NOT BE DETERMINED WITH CERTAINTY HOW MUCH ANESTHETIC WAS ADMINISTERED AND HOW MUCH WAS LOST. A CLOSER EXAMINATION OF THE SYRINGE AND REFILLING WITH NACL SHOWED THAT THE PLUNGER DEFECT IS AND LIQUID IS LOST TO THE TOP. THIS HAS HAPPENED SEVERAL TIMES NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052588 BD DISCARDIT II 20 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1905240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other