BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19341808 · Received May 17, 2024

    Report

    Report Number
    1213809-2024-00294
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS OF TWO 10 ML LUER-LOK CONTROL SYRINGES WERE RECEIVED AND EVALUATED. ONE PHOTO SHOWS TWO SYRINGES: ONE IS LOOSE, FULLY ASSEMBLED, WITH THE TWO FINGER GRIPS BROKEN, AND THE OTHER SHOWS A LOOSE SYRINGE, FULLY ASSEMBLED, WITH THE TWO FINGER GRIPS BROKEN AS WELL, BUT INSIDE A TRANSPARENT PLASTIC BAG. THE SECOND PHOTO SHOWS A CLOSE-UP OF THE SYRINGE WITH BROKEN FINGER GRIPS IN THE TRANSPARENT PLASTIC BAG. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BROKEN FINGER GRIPS DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2349284 AND 4033599 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 2349284 AND OTHER EXPIRATION DATE INCLUDES 2027-11-30. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2022-12-15.

    Description of Event or Problem · 0

    MATERIAL # 309695 LOT # 2349284 / 4033599 IT WAS REPORTED BY CUSTOMER THAT 10ML CONTROL SYRINGE BROKE DURING USE. 10ML CONTROL SYRINGE BROKE DURING USE.

    Description of Event or Problem · 0

    MATERIAL # 309695 LOT # 2349284 / 4033599 IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "10ML CONTROL SYRINGE BROKE DURING USE." VERBATIM: 10ML CONTROL SYRINGE BROKE DURING USE. ADDITIONAL INFORMATION PROVIDED: "I HAVE ATTACHED A COUPLE OF PICTURES. I BELIEVE THEY ARE SELF-EXPLANATORY BUT THE FINGER HOLDS ARE BREADING OFF FROM THE SYRINGE. NO PATIENT HARM WAS NOTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519899 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4033599 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown