BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 12667117 · Received October 20, 2021

    Report

    Report Number
    1710034-2021-00900
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 10, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING AN IN-PROCESS CONTROL IN PRODUCTION THE OPERATOR CHECKED THE CATHETER BATCH NUMBER WHICH SHOULD NORMALLY BEEN 1074200 (SUPPLIER'S BATCH) BUT WHICH WAS IN FACT 1070995."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING AN IN-PROCESS CONTROL IN PRODUCTION THE OPERATOR CHECKED THE CATHETER BATCH NUMBER WHICH SHOULD NORMALLY BEEN 1074200 (SUPPLIER'S BATCH) BUT WHICH WAS IN FACT 1070995."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561307 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 1074200 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown