BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 10091896 · Received May 27, 2020

    Report

    Report Number
    3003152976-2020-00224
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 29, 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: NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1905262 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED ON ANY OF THE SYRINGES TIPS. TIP AND THREAD VERIFICATION TESTS ARE PERFORMED WITHIN THE MANUFACTURING ENVIRONMENT ACCORDING TO PROCEDURE. ALL RETAINED SAMPLES WERE EVALUATED AND VERIFIED TO BE WITHIN SPECIFICATION. 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 BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE TIP BROKE OFF ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MAIL TO INDICATE YOU A QUALITY DEFECT ON SYRINGE. THE TIP BROKE OFF AND GOT STUCK AT THE LUER CONNECTION WITH THE DIFFUSER, WHEN INJECTING THE PRODUCT. THIS HAPPENED TWICE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). 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¿ 50 ML LUER-LOK SYRINGE TIP BROKE OFF ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MAIL TO INDICATE YOU A QUALITY DEFECT ON SYRINGE. THE TIP BROKE OFF AND GOT STUCK AT THE LUER CONNECTION WITH THE DIFFUSER, WHEN INJECTING THE PRODUCT. THIS HAPPENED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554284 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1905262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other