BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

    MDR report key: 16585296 · Received March 21, 2023

    Report

    Report Number
    1710034-2023-00290
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 3, 2023
    Report Date
    May 5, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 13-MAR-2023. INVESTIGATION SUMMARY: BD RECEIVED TWO UNSEALED AND FORTY SEALED 22 GAUGE INSYTE AUTOGUARD UNITS FROM LOT 2243842 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED THAT ONE OF THE UNSEALED UNITS WAS ALREADY RETRACTED WHILE THE OTHER UNIT HAD THE SAFETY BUTTON ENGAGED BUT THE NEEDLE FAILED TO RETRACT. THE CATHETER/ADAPTER ASSEMBLY GOT STUCK ON THE NEEDLE HUB BECAUSE THE TIP ADHESION APPEARED TO STILL BE PRESENT ON THE DEVICE. ONCE THE ADHESION WAS BROKEN AND THE CATHETER WAS ADVANCED OFF THE NEEDLE HUB THE NEEDLE RETRACTED SUCCESSFULLY. THIS UNIT WAS THEN INSPECTED FURTHER TO SEE IF THERE WAS ANY EXCESSIVE ADHESIVE OR GEL PRESENT TO PREVENT THE NEEDLE FROM RETRACTION BUT NONE OF THOSE DEFECTS WERE PRESENT. THE DEVICE WAS THEN RESET TO ITS ORIGINAL POSITION AND THE DEVICE RETRACTED AS EXPECTED. NEXT, THE THREADS INSIDE OF THE CATHETER ADAPTERS WERE INSPECTED BUT NO DAMAGE WAS FOUND TO THE UNITS. FINALLY, THE SEALED UNITS WERE INSPECTED AND A PENETRATION AND DRAG TEST WAS PERFORMED. EACH UNIT PASSED INSPECTION AND WAS FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. A FUNCTIONAL RETRACTION TEST WAS PERFORMED ON TWENTY RANDOMLY SELECTED SEALED UNITS AND EACH UNIT RETRACTED SUCCESSFULLY WITH NO DELAYS OR RESISTANCE FELT. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED ISSUE WITH NEEDLE RETRACTION BUT COULD NOT IDENTIFY ANY ISSUES WITH THE THREADING OR ADVANCEMENT OF THE CATHETERS. IT WAS DETERMINED THAT SINCE THE TIP ADHESION WAS NOT PROPERLY BROKEN IT PREVENTED THE NEEDLE FROM RETRACTING SUCCESSFULLY.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE WOULD NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE CATHETER DOESN'T ADVANCE AND THE RETRACTION BUTTON GETS STUCK. THESE TWO MECHANISMS ARE DEFECTIVE IN RELATION TO ONE ANOTHER AND AS A RESULT BECOMES A FAILED IV.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE WOULD NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: THE CATHETER DOESN'T ADVANCE AND THE RETRACTION BUTTON GETS STUCK. THESE TWO MECHANISMS ARE DEFECTIVE IN RELATION TO ONE ANOTHER AND AS A RESULT BECOMES A FAILED IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355515 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2243842 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown