BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 18498432 · Received January 11, 2024

    Report

    Report Number
    1710034-2023-01524
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 18, 2023
    Report Date
    February 27, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810338
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED 5 PHOTOS AND TWO UNITS OF A 20GX1.00IN INSYTE AUTOGUARD BC DEVICE FROM LOT 3040042 FOR THE INVESTIGATION OF THIS COMPLAINT. THE UNITS ON THE PHOTO APPEAR TO BE THE RETURNED PHYSICAL UNITS. A GROSS VISUAL INSPECTION SHOWS THE NEEDLES ON BOTH UNITS ARE RETRACTED IN THE BARRELS. ONE CATHETER WAS ALSO PROVIDED BUT THE NEEDLE COVERS ARE MISSING. PER THE CUSTOMER¿S VERBATIM THE NEEDLE DID NOT RETRACT WHEN PRESSING THE SAFETY BUTTON AND THEREFORE SENT THE UNITS FOR INVESTIGATION. THE UNITS WERE INVESTIGATED BY REENGAGING THE NEEDLES AND THE SAFETY BUTTON. THE SAFETY BUTTON ACTIVATED WITHOUT DIFFICULTY. AFTER EXAMINATION OF THE UNITS, THE SAFETY BUTTON WAS PRESSED, AND THE NEEDLE RETRACTED WITHOUT RESISTANCE. THE SAME ACTIVITY WAS REPEATED ON BOTH UNIT WITH AN ADDITION THAT THE RETURNED CATHETER WAS PLACED OVER THE NEEDLE. EVEN THEN WHEN PRESSING THE SAFETY BUTTON, THE NEEDLES RETRACTED WITHOUT DIFFICULTY. SINCE THE UNITS RETRACTED SAFELY, THE DEFECT OF NEEDLE RETRACTION FAILURE COULDN¿T BE CONFIRMED ON THE UNITS. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. INVESTIGATION CONCLUSION(S): THE DEFECT OF FAILURE TO RETRACT WAS NOT CONFIRMED. PROBABLE ROOT CAUSE CONCLUSION(S): CANNOT BE DETERMINED IN THE ABSENCE OF A REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING TWO BD INSYTE AUTOGUARD BC SHIELDED IV CATHETERS THE NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT NEEDLE RETRACTION FAILURE. CUSTOMER REPORTED THAT NEEDLE DOES NOT RETRACT WHEN BUTTON IS PRESSED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057736 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3040042 00382903810338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown