BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8056187 · Received November 9, 2018

    Report

    Report Number
    1710034-2018-00800
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 18, 2018
    Report Date
    December 14, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810123
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE IAG PACKAGE FROM LOT NUMBER 8082892. THE CONTENTS WITHIN THE PACKAGE WERE INTACT. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE DAMAGED-DEFECTIVE-OTHER WITH LOT #8082892 ITEM #381012. DHR REVIEW WAS CARRIED OUT. A TOTAL AMOUNT OF 475,000 UNITS WERE MANUFACTURED ON AFA LINE 10 WITH FROM (B)(6) 2018 THROUGH (B)(6) 2018. THE LOT WAS PACKAGED ON PKG LINE 9 FROM (B)(6) 2018 THROUGH (B)(6) 2018. ALL CHALLENGE, SET UP AND IN PROCESS SAMPLES WERE PERFORMED AND PASSED PER SPECIFICATIONS. NO QN¿S WERE INITIATED DURING PRODUCTION. ALTHOUGH THE FAILURE EXPERIENCE WAS CONFIRMED WITH THE RECEIVED UNIT, A DEFINITE SOURCE THAT CAUSED THE DAMAGE (HOLE) ON THE TOP WEB COULD NOT BE DETERMINED. IT IS NOT KNOWN IF IT WAS CAUSED BY THE MANUFACTURING PROCESS, DURING TRANSIT/HANDLING OR AT THE USER SETTING. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER THE PACKAGE HAD A HOLE IN IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE PACKAGE HAD A HOLE IN IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893872 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8082892 00382903810123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other