BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7593484 · Received June 12, 2018

    Report

    Report Number
    1710034-2018-00284
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 22, 2018
    Report Date
    July 26, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT NUMBER 8013892. THE LOT NUMBER WAS BUILT ON AFA LINE 9, FROM JANUARY 17, 2018 THRU JANUARY 20, 2018. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SETUP AND IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. QN / SAP DATABASE REVIEW FINDINGS: THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT STATED IN THE PIR ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. 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. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION. CONCLUSIONS: THE DEFECT LEAKAGE, AS STATED AS THE REPORTED CODE COULD NOT BE IDENTIFIED OR CONFIRMED, AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION AND TESTING. WITHOUT A UNIT FOR EVALUATION; THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR. 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 DURING USE A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOND LEAKING AS "THERE HAVE BEEN 2 INCIDENTS THIS AM FROM SSPU WHERE THE IV WAS PLACED AND THEN A HOLE WAS DISCOVERED, CAUSING BLOOD TO LEAK AND THE NEED FOR A NEW IV TO BE PLACED."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # 5077500. 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 DURING USE A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS FOUND LEAKING AS "THERE HAVE BEEN 2 INCIDENTS THIS AM FROM SSPU WHERE THE IV WAS PLACED AND THEN A HOLE WAS DISCOVERED, CAUSING BLOOD TO LEAK AND THE NEED FOR A NEW IV TO BE PLACED."THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436381 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8013892 30382903825340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other