BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 10 ML SYRINGE

    MDR report key: 10065985 · Received May 18, 2020

    Report

    Report Number
    3002682307-2020-00160
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 26, 2020
    Report Date
    June 22, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1911261 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES WERE EACH TESTED FOR SIGNS OF LEAKAGE; HOWEVER, NO DEFECTS WERE OBSERVED. BASED ON THE PROVIDED CUSTOMER FEEDBACK, IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II 10 ML SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE SUCTION TEST THE AIR PASSES THROUGH THE PISTON. AT THE SLIGHTLY "RESISTIVE" INJECTION (IN A KT OF EPIDURAL IN THIS CASE), THE MEDICATION PASSES BETWEEN THE PLUNGER AND THE BARREL OF THE SYRINGE. CLINICAL CONSEQUENCES: TOTAL LACK OF PRECISION IN THE INJECTION (I HAVE TO MAKE A DOSE OF 3ML, 1 OR 2ML HAVE LEAKED) PRECAUTIONARY MEASURES: APPROXIMATE ESTIMATION OF THE INJECTED DOSE, WHICH IS A VERY IMPORTANT SAFETY MEASURE.

    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 AN UNSPECIFIED NUMBER OF BD DISCARDIT¿ II 10 ML SYRINGES EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE SUCTION TEST THE AIR PASSES THROUGH THE PISTON. AT THE SLIGHTLY "RESISTIVE" INJECTION (IN A KT OF EPIDURAL IN THIS CASE), THE MEDICATION PASSES BETWEEN THE PLUNGER AND THE BARREL OF THE SYRINGE. CLINICAL CONSEQUENCES: TOTAL LACK OF PRECISION IN THE INJECTION (I HAVE TO MAKE A DOSE OF 3ML, 1 OR 2ML HAVE LEAKED). PRECAUTIONARY MEASURES: APPROXIMATE ESTIMATION OF THE INJECTED DOSE, WHICH IS A VERY IMPORTANT SAFETY MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532017 BD DISCARDIT II 10 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1911261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other