BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOCK¿ FEMALE ADAPTER

    MDR report key: 15407166 · Received September 12, 2022

    Report

    Report Number
    2243072-2022-01490
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 18, 2022
    Report Date
    August 20, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: A COMPLAINT OF FOREIGN MATTER BEING FOUND INSIDE A LUER WAS RECEIVED FROM THE CUSTOMER. PHOTOS WERE PROVIDED FOR INVESTIGATION WHERE A CLEAR MATERIAL COULD BE SEEN INSIDE THE LUER HOLE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT#: 2041965 AND NO QUALITY NOTIFICATIONS WERE OPENED AT NAMC RELATED TO THIS CONDITION. AN INVESTIGATION WAS PERFORMED THAT INDICATED THIS CONDITION COULD OCCUR DUE TO A PARTIALLY BROKEN PIN OR FLASH AROUND THE CORE DUE TO A BAD SHUT OFF GENERATED BY A DAMAGE PIN. SINCE NO PHYSICAL SAMPLES WERE AVAILABLE FOR REVIEW AT NAMC, AND NO CAVITY NUMBERS WERE PROVIDED, THE DEFECT COULD NOT BE CONFIRMED. ADDITIONALLY, IT IS UNLIKELY TO BE A TOOLING RELATED FLASH DUE TO THE GEOMETRY DISPLAYED ON THE DEFECTIVE IMAGE. FURTHERMORE, FROM THE MOLD PREVENTATIVE MAINTENANCE RECORD, THERE IS NO INDICATION OF THIS CONDITION BEING PRESENT AT NAMC. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE LUER OF THE BD LUER-LOCK¿ FEMALE ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECT - DEBRIS IN LUER THRU HOLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2591690 BD LUER-LOCK¿ FEMALE ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2041965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown