BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿

    MDR report key: 8086107 · Received November 19, 2018

    Report

    Report Number
    1710034-2018-00827
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 5, 2018
    Report Date
    December 4, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE PROVIDED FOR THIS INCIDENT. DHR REVIEW; WAS CONDUCTED FOR THIS INVESTIGATION. LOT 8080985; WAS BUILT ON AFA LINE 8 ON (B)(6) 2018 THROUGH (B)(6) 2018 AND PACKAGED ON LINE 8 ON (B)(6) 2018 THROUGH (B)(6) 2018 FOR THE QUANTITY OF (B)(4). THERE WAS ONE NON-RELATED IP QN GENERATED DURING THE BUILD OF THIS LOT. ALL REQUIRED CHALLENGE, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SETUP AND IN-PROCESS SAMPLING PLANS. NO UNITS OR PHOTOS WERE PROVIDED FOR OBSERVATION AND/OR TESTING OF THIS INCIDENT THEREFORE THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR. THE PEURA (END USER RISK ANALYSIS) RM5835 REV 14 VERSION (L) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. 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 A "LARGE AMOUNT" OF BLOOD WAS NOTICED IN THE SAFETY COMPARTMENT OF THE BD INSYTE AUTOGUARD WHILE PLACING THE CATHETER IN A SHARPS CONTAINER. BLOOD WAS ALSO NOTICED TO HAVE LEAKED ONTO THE FLOOR, AS WELL AS ON THE CLOTHING AND BARE SKIN ABOVE THE EMPLOYEE'S NITRILE GLOVES. THE EMPLOYEE WAS SAID TO HAVE WASHED THE BLOOD OFF BEFORE NOTICING "AREAS OF REDNESS" THAT HADN'T BEEN PREVIOUSLY IDENTIFIED. IT WAS REPORTED THAT THE EMPLOYEE VISITED THE EMERGENCY DEPARTMENT, WHERE "ALCOHOL WAS WIPED ONTO FF/PM SKIN AND NOTED TO BURN CONFIRMING THIS AREA OF HER SKIN WAS NOT INTACT THUS MAKING HER MORE SUSCEPTIBLE TO AN EXPOSURE".

    Additional Manufacturer Narrative · 1

    OTHER OCCUPATION: ENGINEER / PARAMEDIC / MEDICAL SUPPLY COORDINATOR. 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 A "LARGE AMOUNT" OF BLOOD WAS NOTICED IN THE SAFETY COMPARTMENT OF THE BD INSYTE¿ AUTOGUARD¿ WHILE PLACING THE CATHETER IN A SHARPS CONTAINER. BLOOD WAS ALSO NOTICED TO HAVE LEAKED ONTO THE FLOOR, AS WELL AS ON THE CLOTHING AND BARE SKIN ABOVE THE EMPLOYEE'S NITRILE GLOVES. THE EMPLOYEE WAS SAID TO HAVE WASHED THE BLOOD OFF BEFORE NOTICING "AREAS OF REDNESS" THAT HADN'T BEEN PREVIOUSLY IDENTIFIED. IT WAS REPORTED THAT THE EMPLOYEE VISITED THE EMERGENCY DEPARTMENT, WHERE "ALCOHOL WAS WIPED ONTO FF/PM SKIN AND NOTED TO BURN CONFIRMING THIS AREA OF HER SKIN WAS NOT INTACT THUS MAKING HER MORE SUSCEPTIBLE TO AN EXPOSURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923713 BD INSYTE¿ AUTOGUARD¿ INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8080985 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention