BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MEDICAL SYSTEMS

    MDR report key: 506240 · Received January 2, 2004

    Report

    Report Number
    506240
    Event Type
    Malfunction
    Date Received
    January 2, 2004
    Date of Event
    September 19, 2003
    Report Date
    December 17, 2003
    Manufacturer
    BD MEDICAL SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 06/07/04: LOT HISTORY REVIEW: NO. A REVIEW OF THE MRR DATABASE REVEALED NO REJECT ACTIVITY ASSOCIATED WITH THIS COMPLAINT. OBSERVATIONS AND TESTING: RECEIVED 1 USED CATHETER WITH NO PACKAGING. THE TECHNICIAN PERFORMED A VISUAL AND MICROSCOPIC EXAMINATION. THE ADAPTER WAS COMPLETELY BROKEN IN HALF JUST ABOVE THE TAB. THE INSIDE RIM AND THREAD AREA WERE UNDAMAGED. THE DAMAGE DID NOT APPEAR TO RUN LENGTHWISE THROUGH THE ADAPTER. NO OTHER STRESS FRACTURES WERE VISIBLE. CONCLUSIONS: THE INSPECTION REVEALED A BROKEN ADAPTER. IT IS UNCLEAR IF THE DAMAGE WAS CAUSED BY MANUFACTURING OR THE USER (AS STATED BY THE CUSTOMER THE ADAPTER MAY HAVE BEEN UNLUER LOCKED WITH A HEMOSTAT). CRACKED ADAPTER DAMAGE CAN OCCUR DURING THE MANUFACTURING PROCESS. UNABLE TO IMPLEMENT, CORRECTIVE ACTION. THE CAUSE OF THE PROBLEM WAS INDETERMINABLE. THERE ARE SEVERAL VISION SYSTEMS AND MANUAL INSPECTION STATIONS TO VERIFY THAT NO DAMAGE IS OCCURRING TO THE PARTS DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    USED BD IV CATHETER TO START IV. WHEN NURSE ATTEMPTED TO CONNECT IV FLUID, THE IV CATHETER HUB BROKE. IV CATH REMOVED AND NEW IV STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD MEDICAL SYSTEMS INSYTE-N AUTOGUARD WINGED FOZ BD MEDICAL SYSTEMS * 2254748

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other