BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC

    MDR report key: 9285294 · Received November 6, 2019

    Report

    Report Number
    1710034-2019-01184
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 18, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE USED UNIT FROM LOT NUMBER 9140543 IN OPENED PACKAGING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. UPON VISUAL INSPECTION THE BUTTON IS NOT COMPRESSED, AND THE UNIT IS NOT RETRACTED. NO DAMAGE OR MIS-MOLDING WAS OBSERVED ALONG THE GRIP OR BARREL OF THE UNIT. INSPECTION OF THE BUTTON/HUB DID NOT SHOW ANY SIGNS OF DAMAGE OR MIS-MOLDING THE UNIT WAS INSPECTED FOR EXCESS GEL AND ADHESIVE THAT CAN PREVENT THE NEEDLE FROM RETRACTING PROPERLY. THE GEL WAS COMPARED TO THAT OF CONTROL SAMPLES AND INSPECTED TO BE STANDARD PER PRODUCTION NOT EFFECTING FORM OR FUNCTION. INSPECTION FOR ADHESIVE REVEALED SOME ADHESIVE ON THE GRIP AND HUB. THE UNIT WAS THEN TESTED FOR NEEDLE RETRACTION. THE BUTTON WAS PRESSED, AND HIGH RESISTANCE WAS PRESENT, AND THE BUTTON DID NOT MOVE. THIS ADHESIVE SHOWN ABOVE PREVENTS THE BUTTON FROM SLIDING IN ITS CHANNEL PREVENTING RETRACTION AND THE HUB FROM ROTATING OR RETRACTING. CONCLUSION(S): DETERMINED: THE ROOT CAUSE FOR NEEDLE RETRACTION FAILURE WAS FOUND TO BE ADHESIVE ON THE BUTTON PREVENTING ACTIVATION OF THE RETRACTION MECHANISM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NEEDLE DOES NOT CLICK BACK AFTER PUNCTURING OUR PATIENT. HOWEVER, THIS IS THE INTENTION. IT IS ABOUT THE BD INSYTE AUTOGUARD BC WINGED TYPE 22 GAX1.00 IN 0.9X25MM."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE NEEDLE DOES NOT CLICK BACK AFTER PUNCTURING OUR PATIENT. HOWEVER, THIS IS THE INTENTION. IT IS ABOUT THE BD INSYTE AUTOGUARD BC WINGED TYPE 22 GAX1.00 IN 0.9X25MM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077644 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9140543

    Patients

    Seq Age Sex Outcome Treatment
    1 Other