BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 9180548 · Received October 11, 2019

    Report

    Report Number
    3003152976-2019-00716
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 24, 2019
    Report Date
    December 3, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO AND ONE VIDEO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTION OF BOTH THE VIDEO AND PHOTO, A LEAK WAS OBSERVED BETWEEN THE STOPPER RIBS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1905224, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1905224 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 LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE AT THE PLUNGER SITE WHEN USING THE SYRINGE. WE USE THESE SYRINGES FOR CYTOTOXIC DRUG, IT IS THEREFORE A DANGER FOR US WHEN THIS DEFECT OCCURS. THERE IS A DEVICE AVAILABLE, HOWEVER CONTAMINATED WITH 5F-FLUOROURACILE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE AT THE PLUNGER SITE WHEN USING THE SYRINGE. WE USE THESE SYRINGES FOR CYTOTOXIC DRUG, IT IS THEREFORE A DANGER FOR US WHEN THIS DEFECT OCCURS. THERE IS A DEVICE AVAILABLE, HOWEVER CONTAMINATED WITH 5F-FLUOROURACILE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977121 BD PLASTIPAK 50ML LUER-LOK SYRINGE SRINGE FMF BECTON DICKINSON, S.A. 1905224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other