BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 9835881 · Received March 16, 2020

    Report

    Report Number
    3003152976-2020-00134
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 24, 2020
    Report Date
    April 8, 2020
    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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SAMPLE WAS RETURNED. UPON RECEIPT, THE PRODUCT WAS INDICATED TO BE CHEMO CONTAMINATED AND UNFORTUNATELY, COULD NOT BE EVALUATED. THREE PHOTOS WERE ALSO PROVIDED TO OUR QUALITY TEAM THE PHOTOS WERE VISUALLY INSPECTED AND A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1904262, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1904262 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE LEAKED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE. DURING DRAWING NORMAL SALINE, THE N/S LEAKED THROUGH STOPPER, ONE ACTUAL SAMPLE WILL BE DELIVERED TO YOU FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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 BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE LEAKED. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE. DURING DRAWING NORMAL SALINE, THE N/S LEAKED THROUGH STOPPER, ONE ACTUAL SAMPLE WILL BE DELIVERED TO YOU FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301751 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1904262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other