BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM)

    MDR report key: 9591931 · Received January 15, 2020

    Report

    Report Number
    1710034-2020-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 21, 2019
    Report Date
    February 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE FOR EVALUATION. BD RECEIVED A TOP WEBBING, CATHETER/ADAPTER ASSEMBLY, AND A NEEDLE COVER FROM ITEM NUMBER 381512, LOT NUMBER 9193539. ANY TESTING OR EXAMINATIONS COULD NOT BE PERFORMED FOR THE REPORTED DEFECT OF NEEDLE RETRACTION FAILURE AS THE NEEDLE, GRIP, AND BARREL ASSEMBLY WERE NOT RETURNED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381512 BATCH NO: 9193539. EVENT DESCRIPTION: I HAVE A DEFECTIVE BD INSYTE¿ AUTOGAURD¿ WINGED. REF (B)(4). LOT: 9193539. ISSUE: NEEDLE DID NOT RETRACT AS USUAL. NO PATIENT HARM REPORTED. I HAVE THE ITEM (OR WHAT WAS SAVED OF IT) AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381512, BATCH NO: 9193539. EVENT DESCRIPTION: I HAVE A DEFECTIVE BD INSYTE¿ AUTOGAURD¿ WINGED. REF 381512 24 GAX0/75 IN LOT: 9193539. ISSUE: NEEDLE DID NOT RETRACT AS USUAL. NO PATIENT HARM REPORTED. I HAVE THE ITEM (OR WHAT WAS SAVED OF IT) AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57312 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381512 9193539 30382903815129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other