BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9592129 · Received January 15, 2020

    Report

    Report Number
    1710034-2020-00007
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE SEMI RETRACTED UNIT FROM ITEM NUMBER 381412, LOT NUMBER 9122769. IN ADDITION, THREE PHOTOGRAPHS WERE SUBMITTED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. UPON VISUAL INSPECTION OF THE UNIT IT WAS NOTED THAT THE CANNULA IS STICKING OUT OF THE GRIP BY APPROXIMATELY A HALF INCH. THE SPRING IS CLOSELY BOUND AND OVERLAPPED NEAR THE BOTTOM OF THE SPRING. THIS CAN PREVENT THE SPRING FROM EXPANDING AND REACHING ITS FULL LENGTH ALLOWING FOR THE NEEDLE TO STICK OUT. THE UNIT WAS PULLED APART AND THE GRIP, HUB, AND SPRING WERE INSPECTED FOR DAMAGE. DURING THE MICROSCOPIC INSPECTION DAMAGE WAS OBSERVED ON THE HUB. FURTHER INSPECTION REVEALED THAT THE HUB WAS DAMAGED, AND THE SPRING WAS GETTING CAUGHT DURING RETRACTION PREVENTING THE NEEDLE FROM FULLY RETRACTING INTO THE SAFETY HANDLE. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING EQUIPMENT RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO MISALIGNMENT. 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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DID NOT RETRACT AFTER USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "24 GA X 0.75 IN REF 381412 LOT NUMBER IS 9122769 THE NEEDLE DID NOT RETRACT INTO THE BARREL AS IT SHOULD HAVE DONE."

    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¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE DID NOT RETRACT AFTER USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "24 GA X 0.75 IN REF 381412 LOT NUMBER IS 9122769 THE NEEDLE DID NOT RETRACT INTO THE BARREL AS IT SHOULD HAVE DONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57349 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381412 9122769 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other