BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15364167 · Received September 6, 2022

    Report

    Report Number
    1710034-2022-00480
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    August 11, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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

    H6: INVESTIGATION SUMMARY A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 2021886, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED MEDIA PRESENT IN THE ADAPTER WITH A BENT CATHETER. THERE ALSO APPEARED TO BE BLOOD IN THE THREADS OF THE CONNECTED DEVICE, BUT LEAKAGE COULD NOT BE VERIFIED FROM THE PROVIDED PHOTO. A PHYSICAL DEVICE WOULD NEED TO BE PROVIDED FOR FURTHER INSPECTION. THEREFORE, BASED OFF THE PROVIDED PHOTO THE REPORTED DEFECT COULD NOT BE VERIFIED. 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 THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE NOTED AT CONNECTION POINT OF BD ANGIOCATH 22G AND ONE-LINK CATHETER EXTENSION SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE NOTED AT CONNECTION POINT OF BD ANGIOCATH 22G AND ONE-LINK CATHETER EXTENSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2635042 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 2021886 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown