BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 16076248 · Received December 30, 2022

    Report

    Report Number
    1710034-2022-00871
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 12, 2022
    Report Date
    February 8, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2216568, MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025, DEVICE MANUFACTURE DATE: 17-AUG-2022. MEDICAL DEVICE LOT #: 2243842, MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2025, DEVICE MANUFACTURE DATE: 31-AUG-2022. 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: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SAFETY MECHANISM WOULD NOT RETRACT THE NEEDLE DURING USE. THIS OCCURRED ONCE EACH IN LOTS 2216568 AND 2243842. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFETY MECHANISM WAS NOT RETRACTING THE NEEDLE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SAFETY MECHANISM WOULD NOT RETRACT THE NEEDLE DURING USE. THIS OCCURRED ONCE EACH IN LOTS 2216568 AND 2243842. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SAFETY MECHANISM WAS NOT RETRACTING THE NEEDLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355363 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 SEE H10 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown