BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP DISINFECTION SINGLES CE

    MDR report key: 21360733 · Received February 11, 2025

    Report

    Report Number
    1911916-2025-00094
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 31, 2025
    Report Date
    March 4, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    QBP
    UDI-DI
    00382903065967
    PMA / PMN Number
    K193190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    EXTERNAL REF # (B)(4). MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT CLINICIAN ENCOUNTERED CRACKING WHILE USING BD PUREHUB¿ DISINFECTING CAP SINGLE (SKU 306598) TO DISINFECT NEEDLE-FREE LUER CONNECTORS PRIOR TO I.V. ACCESS AND TO ACT AS A PHYSICAL BARRIER BETWEEN LINE ACCESSES. CLINICIAN EXPERIENCED: TIENDE A PARTIRSE CUANDO SE DA VARIAS VUELTAS AL PRODUCTO O SE HA UTLIZADO DURANTE MÁS DE UN TURNO - TENDS TO CRACK WHEN THE PRODUCT IS TURNED SEVERAL TIMES OR HAS BEEN USED FOR MORE THAN ONE SHIFT. -TAPÓN ROTO CON UNA GRIETA - BROKEN CAP WITH A SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857932 CAP DISINFECTION SINGLES CE CAP, DEVICE DISINFECTANT QBP BECTON DICKINSON UNKNOWN 00382903065967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown