BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9475758 · Received December 16, 2019

    Report

    Report Number
    1710034-2019-01334
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 28, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED TWO OPENED UNITS AND ONE UNOPENED UNIT FROM LOT NUMBER 9170870. A FUNCTIONAL TEST WAS PERFORMED WHERE ALL UNITS TESTED SUCCESSFULLY RETRACTED PER SPECIFICATIONS. NO DEFECT WAS OBSERVED. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SAFETY MECHANISM DELAY OCCURRED AFTER USE WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SAFETY MECHANISM DELAYED RETRACT. WHEN PUSH BUTTON, THE SPEED OF NEEDLE RETRACT BECAME SLOWER THAN PREVIOUS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SAFETY MECHANISM DELAY OCCURRED AFTER USE WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SAFETY MECHANISM DELAYED RETRACT. WHEN PUSH BUTTON, THE SPEED OF NEEDLE RETRACT BECAME SLOWER THAN PREVIOUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271872 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 9170870 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other