BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 15929454 · Received December 6, 2022

    Report

    Report Number
    2243072-2022-02117
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 13, 2022
    Report Date
    January 12, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814336
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE DIDN'T RETRACT PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MULTIPLE INSTANCES OF INSYTE AUTOGUARD NOT RETRACTING. REFERENCES BUTTON IS STICKING. CUSTOMER ALSO STATES THERE WAS ALSO DIRTY NEEDLE STICK. UNKNOWN OF THE NEEDLE STICK INJURY WAS A RESULT OF NON RETRACTION. D1: MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. D4: UDI # (B)(4). D4: CATALOG # 381433 D4: MEDICAL DEVICE LOT #: 381433 D4: MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024 H4: DEVICE MANUFACTURE DATE: 06-JUL-2021 G2: MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.5. PMA / 510(K)#: K201075 H6: 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.

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, (B)(4). DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE DIDN'T RETRACT PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MULTIPLE INSTANCES OF INSYTE AUTOGUARD NOT RETRACTING. REFERENCES BUTTON IS STICKING. CUSTOMER ALSO STATES THERE WAS ALSO DIRTY NEEDLE STICK. UNKNOWN OF THE NEEDLE STICK INJURY WAS A RESULT OF NON RETRACTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING UNSPECIFIED BD INSYTE AUTOGUARD THE NEEDLE DIDN'T RETRACT PROPERLY AND A DIRTY NEEDLESTICK OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES MULTIPLE INSTANCES OF INSYTE AUTOGUARD NOT RETRACTING. REFERENCES BUTTON IS STICKING. CUSTOMER ALSO STATES THERE WAS ALSO DIRTY NEEDLE STICK. UNKNOWN OF THE NEEDLE STICK INJURY WAS A RESULT OF NON RETRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576912 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381433 1187258 00382903814336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown