BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8241898 · Received January 11, 2019

    Report

    Report Number
    1710034-2018-01008
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 1, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 11TH RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT #8192723 REGARDING ITEM #382523. A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AFA LINE 12 FROM 13JUL18 THROUGH 18JUL18. REVIEW OF DHR REVEALED WERE 3 INSTANCES WHERE THE CHALLENGE SAMPLES WERE NOT NOTED AS PASS OR FAIL (REJECT WEDGE CHALLENGE, PLUG DEPTH ATTRIBUTE CHALLENGE AND SPLAY LUBE CHALLENGE), OF WHICH NONE WERE RELATED TO THIS INCIDENT. ALL REQUIRED SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. THESE NON-RECORDED (PASS/FAIL) CHALLENGES ARE BEEN ADDRESSED BY THE QE. REVIEW DISCLOSED ONE NON -RELATED QN WAS INITIATED; DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED AS PER CONTROL PLAN. INVESTIGATION CONCLUSION: THE DEFECT NEEDLE RETRACTION FAILURE; COULD NOT BE IDENTIFIED OR CONFIRMED, AND CAUSE COULD NOT BE DETERMINED, AS THE UNITS DESCRIBED IN THE PRODUCT INCIDENT REPORT WERE NOT RETURNED FOR EVALUATION AND TESTING. ROOT CAUSE DESCRIPTION: 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. RATIONALE: 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. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE WOULDN'T RETRACT AFTER STARTING THE IV.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 SHIELDED IV CATHETER NEEDLE WOULDN'T RETRACT AFTER STARTING THE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33640 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8192723 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other