BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMALE LL ADAPTOR

    MDR report key: 11068079 · Received December 23, 2020

    Report

    Report Number
    2243072-2020-02137
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    March 16, 2020
    Report Date
    February 17, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    1024156043
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PICTURES OF THE SAMPLES OF THE MODEL 1024-156-043 WERE RECEIVED. THE PICTURES WERE REVIEWED, AND IT WAS OBSERVED A DAMAGE IN INTERNAL SIDE OF THE SAMPLES CONFIRMING THE REPORTED FAILURE MODE. SINCE THE REPORTED MODEL IS SUPPLIER RELATED, A MANUFACTURING INFORMATION WAS REQUESTED, THE SUPPLIER CONDUCTED A DHR REVIEW AND NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOT REGARDING TO THE DIRT IN THE COMPONENT AND IT WAS MANUFACTURED ACCORDING WITH SUPPLIER INTERNAL PROCEDURE, SINCE THE MOLD WAS TRANSFERRED AND NO ISSUES WERE FOUND DURING MANUFACTURING, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FEMALE LL ADAPTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 1024-156-043 BATCH NO: 0004081219, 0004081258, 0004081220, 0004081222, 0001068184 IT WAS REPORTED THAT THERE WERE 57 COMPLAINTS RECEIVED THIS YEAR ABOUT A REJECTION FOR A BROKEN LUER ON THE EDGE OF THE COMPONENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMALE LL ADAPTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 1024-156-043 BATCH NO: 0004081219, 0004081258, 0004081220, 0004081222, 0001068184. IT WAS REPORTED THAT THERE WERE 57 COMPLAINTS RECEIVED THIS YEAR ABOUT A REJECTION FOR A BROKEN LUER ON THE EDGE OF THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529747 FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 0004081258 1024156043

    Patients

    Seq Age Sex Outcome Treatment
    1