BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7992019 · Received October 22, 2018

    Report

    Report Number
    1710034-2018-00751
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    September 30, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE PAPER TOP WEB (LABEL) FROM THE LOT NUMBER 8100635. DHR REVIEW WAS PERFORMED ON LOT NUMBER 8002767. THE LOT NUMBER WAS BUILT ON AFA LINE 4 FROM 12APR2018 THROUGH 13APR2018. PACKAGED ON PACKAGING LINE 10 FROM 23APR2018 THROUGH 24APR2018. 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. THE DEFECT THREADING DIFFICULT; 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. ONLY A PACKAGE LABEL WAS RETURNED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER "STICKS AND REFUSES TO ADVANCE" IN THE PATIENT'S VEIN, RESULTING IN "ALTERNATIVE FORM OF GLUCOSE MAINTENANCE (GASTRIC FEEDS) AND IM INJECTIONS FOR SCHEDULED ANTIBIOTICS".

    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-N¿ AUTOGUARD¿ SHIELDED IV CATHETER "STICKS AND REFUSES TO ADVANCE" IN THE PATIENT'S VEIN, RESULTING IN "ALTERNATIVE FORM OF GLUCOSE MAINTENANCE (GASTRIC FEEDS) AND IM INJECTIONS FOR SCHEDULED ANTIBIOTICS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833301 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8100635 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention