BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19341812 · Received May 17, 2024

    Report

    Report Number
    1213809-2024-00295
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 16, 2024
    Report Date
    November 7, 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

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWO SAMPLES OF TWO 10 ML LUER-LOK CONTROL SYRINGES (P/N 309695) WERE RECEIVED AND EVALUATED. ONE CARTON LABEL AFFIXED TO CARDBOARD WAS CUT-OUT AND INCLUDED IN THE BAG: HOWEVER, THE BATCH STATES 3206230. BOTH SAMPLES WERE RECEIVED LOOSE WITH THE TWO FINGER GRIPS BROKEN. THE REPORTED BATCH IN THE VERBATIM STATES 4033599; HOWEVER, THE BATCH NUMBER ON THE BOX LABEL INCLUDED WITH THE SAMPLES IS 3206230. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE BROKEN FINGER GRIPS DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    MATERIAL # 309695, LOT # 4033599. IT WAS REPORTED THAT THE BD LUER-LOK BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT SYRINGE BREAKING WHILE THE DOCTOR WAS USING THE PRODUCT ON A PATIENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS IS THE THIRD REPORT OF THE 10ML CONTROL SYRINGE BY BD, #309695. BREAKING WHILE THE DOCTOR WAS USING THE PRODUCT ON A PATIENT. NO PATIENT HARM REPORTED. THE FIRST TWO REPORTS WERE FROM LOT# 2349284, THIS TIME IT IS OUT OF LOT# 4033599.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520915 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4033599 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown