BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 13196613 · Received January 7, 2022

    Report

    Report Number
    9610048-2021-00177
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 11, 2021
    Report Date
    February 1, 2022
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811374
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A VIDEO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1153299, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED VIDEO AND OBSERVED THAT THERE WAS A LEAK BETWEEN THE CATHETER/ADAPTER CONNECTION. BASED OFF THE EVIDENCE PROVIDED IN THE VIDEO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR TESTING A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ANGIOCATH¿ IV CATHETER THERE WAS LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NURSE REPORTED THE ANGIOCATH TUBE WAS LEAKING AT THE MIDDLE CONNECTION OF THE BASE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ANGIOCATH¿ IV CATHETER THERE WAS LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NURSE REPORTED THE ANGIOCATH TUBE WAS LEAKING AT THE MIDDLE CONNECTION OF THE BASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992241 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381137 1153299 30382903811374

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown