BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50 ML BD PLASTIPAK LUER-SLIP SYRINGE

    MDR report key: 9416097 · Received December 5, 2019

    Report

    Report Number
    3003152976-2019-00827
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 20, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. THROUGH VISUAL INSPECTION, A LEAKAGE BETWEEN THE STOPPER RIBS WAS OBSERVED. FURTHER INSPECTION DID NOT IDENTIFY ANY DAMAGE IN THE PLUNGER ROD OR OTHER COMPONENTS THAT COULD HAVE CAUSED A LEAK AND THE STOPPER WAS PROPERLY ASSEMBLED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1903323, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1903323 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 ML BD PLASTIPAK¿ LUER-SLIP SYRINGE LEAKED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DRUG LEAKAGE FROM THE STOPPER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 50 ML BD PLASTIPAK¿ LUER-SLIP SYRINGE LEAKED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DRUG LEAKAGE FROM THE STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215360 50 ML BD PLASTIPAK LUER-SLIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300866 1903323 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other