BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD US CATHENA 20GX1.25IN STRAIGHT BC

    MDR report key: 20173975 · Received September 9, 2024

    Report

    Report Number
    2243072-2024-00955
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903868636
    PMA / PMN Number
    K220584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCH. FROM THE RETURNED SAMPLE, OBSERVED THAT THE SAFETY MECHANISM WAS ACTIVATED; NO SAFETY ACTIVATION FAILURE WAS OBSERVED. HENCE, THE REPORTED DEFECT WAS NOT OBSERVED. AS CURRENT CONTROLS, THERE ARE DAILY OUTGOING AND IN-PROCESS FUNCTIONAL TEST TO CHECK AND DETECT SAFETY ACTIVATION FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD US CATHENA 20GX1.25IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT THEY HAVE ANOTHER FAILED SHARP GUARD. IT WAS TOLD THAT THE BLUE PIECE SEPARATES AND THE GUARD STAYS IN THE PLASTIC HOUSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I HAVE ANOTHER FAILED SHARP GUARD. I WAS TOLD THAT THE BLUE PIECE SEPARATES AND THE GUARD STAYS IN THE PLASTIC HOUSING. LOT 4116856. I HAVE THE PRODUCT. XXXXXXXXX XXXXXXXXXX MS RN NPD-BC ACNS-BC CLINICAL NURSE SPECIALIST ED/TRINITY HEALTH GRAND RAPIDS PRONOUNS: SHE/HER/HERS XXXXXXXXXXXXXXXXXXXXXX

    Description of Event or Problem · 0

    MATERIAL #:386863; BATCH#:4116856. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE ANOTHER FAILED SHARP GUARD. IT WAS TOLD THAT THE BLUE PIECE SEPARATES AND THE GUARD STAYS IN THE PLASTIC HOUSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE ANOTHER FAILED SHARP GUARD. I WAS TOLD THAT THE BLUE PIECE SEPARATES AND THE GUARD STAYS IN THE PLASTIC HOUSING. LOT 4116856. I HAVE THE PRODUCT. MS RN NPD-BC ACNS-BC. CLINICAL NURSE SPECIALIST. (B)(6). PRONOUNS: SHE/HER/HERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022106 BD US CATHENA 20GX1.25IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4116856 00382903868636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown