BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC

    MDR report key: 7982047 · Received October 18, 2018

    Report

    Report Number
    1710034-2018-00746
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 27, 2018
    Report Date
    December 14, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONLY A VIDEO WAS SUBMITTED FOR REVIEW. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF CATHETER DEFECTIVE / DAMAGED WITH LOT #8157541 REGARDING ITEM #38101214. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8031566. THE LOT NUMBER WAS BUILT ON AFA LINE 10 FROM 08FEB2018 THRU 09FEB2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. ALTHOUGH THE PHOTO DISPLAYED THE CATHETER/ADAPTER DEFECTIVE, UNCERTAIN WHERE THE DEFECT OCCURRED. THE UNIT WAS NOT RETURNED FOR EVALUATION AND TESTING. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC HAD A HOLE BETWEEN THE HUB AND THE BEVEL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT UNK - THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). OTHER OCCUPATION: (B)(6) - INFORMATION AND SECURITY SERVICE OF MEDICINES. 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 THE BD INSYTE¿ AUTOGUARD¿ BC HAD A HOLE BETWEEN THE HUB AND THE BEVEL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817319 BD INSYTE¿ AUTOGUARD¿ BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8157541

    Patients

    Seq Age Sex Outcome Treatment
    1 Other