BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN

    MDR report key: 14515993 · Received May 26, 2022

    Report

    Report Number
    1710034-2022-00271
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 1, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1090017, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING NEAR THE NOSE OF THE ADAPTER. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN THE DEVICE WAS DAMAGED DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PERFORMING THE VENIPUNCTURE ON THE PATIENT AND TRYING TO REMOVE THE CATHETER, IT COMES OUT WITH A BROKEN CORE. ADDITIONAL INFORMATION BY RCC: THE CATHETER THAT WAS PRESENTED WAS BROKEN, NOT THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN THE DEVICE WAS DAMAGED DURING USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PERFORMING THE VENIPUNCTURE ON THE PATIENT AND TRYING TO REMOVE THE CATHETER, IT COMES OUT WITH A BROKEN CORE. ADDITIONAL INFORMATION BY RCC: THE CATHETER THAT WAS PRESENTED WAS BROKEN, NOT THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803843 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA 1.00IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381823 1090017 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown