BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19273602 · Received May 8, 2024

    Report

    Report Number
    1213809-2024-00275
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    March 3, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED, A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE UNNECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL # 309659, BATCH # 3212670. IT WAS REPORTED BY CUSTOMER THAT WHEN NEEDING TO USE ON SUB OUT PORT, SYRINGE DOES NOT SECURELY ATTACH TO MICRO CLAVE, RESULTING IN MEDICATION LEAKING AND SYRINGE DETACHMENT, RESULTING IN A POTENTIAL FOR AN ADVERSE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN NEEDING TO USE ON SUB OUT PORT, SYRINGE DOES NOT SECURELY ATTACH TO MICRO-CLAVE, RESULTING IN MEDICATION LEAKING AND SYRINGE DETACHMENT, RESULTING IN A POTENTIAL FOR AN ADVERSE. CAT# OF PRODUCT BEING COMPLAINED: 309659. DESCRIPTION OF PRODUCT: SYRINGE TUBERCULIN L/SL ST 1ML DISP CLR SCALE 200EA/BX 8BX/CA. LOT NUMBER: 3212670.

    Description of Event or Problem · 0

    MATERIAL # 309659. BATCH # 3212670. IT WAS REPORTED THAT THE BD LUER-LOK HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN NEEDING TO USE ON SUB OUT PORT, SYRINGE DOES NOT SECURELY ATTACH TO MICRO CLAVE, RESULTING IN MEDICATION LEAKING AND SYRINGE DETACHMENT, RESULTING IN A POTENTIAL FOR AN ADVERSE." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN NEEDING TO USE ON SUB OUT PORT, SYRINGE DOES NOT SECURELY ATTACH TO MICRO-CLAVE, RESULTING IN MEDICATION LEAKING AND SYRINGE DETACHMENT, RESULTING IN A POTENTIAL FOR AN ADVERSE. CAT# OF PRODUCT BEING COMPLAINED: 309659. DESCRIPTION OF PRODUCT: SYRINGE TUBERCULIN L/SL ST 1ML DISP CLR SCALE 200EA/BX 8BX/CA LOT NUMBER: 3212670.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101248 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3212670 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown