BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.56IN (0.7 X 14 MM)

    MDR report key: 9923424 · Received April 3, 2020

    Report

    Report Number
    1710034-2020-00239
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 14, 2020
    Report Date
    May 19, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH TWO PHOTOS OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 9211124, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS BUT COULD NOT IDENTIFY THE REPORTED FAILURE. THE PHOTO SHOWED A 24 GAUGE INSYTE AUTOGUARD CATHETER UNIT WITH THE COVER REMOVED, THE ACTIVATION BUTTON COMPLETELY DEPRESSED WITH THE NEEDLE FULLY RETRACTED AND THE CATHETER/ADAPTER ASSEMBLY LOOSED FROM THE UNIT. THERE WAS NO VISUAL DAMAGE OR DEFECT OBSERVED. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS COULD BE IDENTIFIED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.56IN (0.7 X 14 MM) WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE, PRIOR TO USE THE CATHETER IN THE PATIENT, NOTICED A QUALITY DEFECT IN THE CATHETER. SHE NOTES A CRACK IN ITS PASTE BATCH: 9211124".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.56IN (0.7 X 14 MM) WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE, PRIOR TO USE THE CATHETER IN THE PATIENT, NOTICED A QUALITY DEFECT IN THE CATHETER. SHE NOTES A CRACK IN ITS PASTE BATCH: 9211124."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389097 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.56IN (0.7 X 14 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9211124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other