BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 10078593 · Received May 21, 2020

    Report

    Report Number
    1710034-2020-00320
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    April 18, 2020
    Report Date
    June 16, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826347
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN EXPERIENCED CATHETER DAMAGE/DEFORMATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382634 BATCH NO.: 0032351 BD INSYTE AUTOGUARD BC WINGED IV CATHETER SPLIT DOWN THE MIDDLE OF PLASTIC CATHETER DURING INSERTION. ONLY REPORTED 1 EACH AS DEFECTIVE IN THE SAFE, BUT APPARENTLY HAVE HAD ISSUES IN THE PAST BUT WERE NOT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN EXPERIENCED A CATHETER THAT BROKE/SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382634 BATCH NO.: 0032351. BD INSYTE AUTOGUARD BC WINGED IV CATHETER SPLIT DOWN THE MIDDLE OF PLASTIC CATHETER DURING INSERTION. ONLY REPORTED 1 EACH AS DEFECTIVE IN THE SAFE, BUT APPARENTLY HAVE HAD ISSUES IN THE PAST BUT WERE NOT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN EXPERIENCED CATHETER DAMAGE/DEFORMATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382634 BATCH NO.: 0032351 BD INSYTE AUTOGUARD BC WINGED IV CATHETER SPLIT DOWN THE MIDDLE OF PLASTIC CATHETER DURING INSERTION. ONLY REPORTED 1 EACH AS DEFECTIVE IN THE SAFE, BUT APPARENTLY HAVE HAD ISSUES IN THE PAST BUT WERE NOT REPORTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN 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 WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 20GA 1.16IN EXPERIENCED A CATHETER THAT BROKE/SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382634, BATCH NO.: 0032351. BD INSYTE AUTOGUARD BC WINGED IV CATHETER SPLIT DOWN THE MIDDLE OF PLASTIC CATHETER DURING INSERTION. ONLY REPORTED 1 EACH AS DEFECTIVE IN THE SAFE, BUT APPARENTLY HAVE HAD ISSUES IN THE PAST BUT WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541596 SEE H10 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382634 0032351 30382903826347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other