BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7809691 · Received August 23, 2018

    Report

    Report Number
    1710034-2018-00566
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    June 28, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825340
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER D.8. DEVICE SINGLE USE?: NO H.3. DEVICE RETURNED TO MANUFACTURE: YES INVESTIGATION SUMMARY: RECEIVED ONE USED IAG/BC 20GA CATHETER/ADAPTER ASSEMBLY AND A PACKAGE LABEL. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LUER FITTINGS INCOMPATIBLE WITH LOT #8003743 REGARDING ITEM #382534. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE WITH LOT #8003743 REGARDING ITEM #382534. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8003743; THE LOT NUMBER WAS BUILT / PACKAGE ON AFA LINE 12 FROM JANUARY 5, 2018 THRU JANUARY 10, 2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. VISUAL/MICROSCOPIC EVALUATION DISCLOSED NO MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED OUTSIDE THREADS, OR THE INSIDE RIM OF THE LUER ADAPTER. A FUNCTIONAL ASSESSMENT OF THE CONNECTION COMPATIBILITY OF THE RETURNED UNIT AND BDD 10ML SYRINGE WAS EVALUATED. THERE WAS A SUCCESSFUL CONNECTION BETWEEN THE RETURNED CATHETER/ADAPTER ASSEMBLY AND THE SYRINGE. IN A LEAK TEST THE MALE LUER OF A LAB SUPPLIED BD 10ML SYRINGE FILLED WITH RED FLUID WAS CONNECTED TO THE FEMALE LUER OF THE ADAPTER. THE CONNECTION WAS SUCCESSFUL; OBSERVED THERE WAS NO LEAKAGE IN ANY AREA OF THE UNIT. PROBABLE ROOT CAUSE FOR THE INCIDENT IS INDETERMINATE. THE RETURNED CATHETER/ADAPTER UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, PER THE PIR. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED CATHETER/ADAPTER ASSEMBLY. 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 SHIELDED IV CATHETER WAS LEAKING AND WOULDN'T SECURE TO THE TUBING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS LEAKING AND WOULDN'T SECURE TO THE TUBING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652407 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8003743 30382903825340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other