BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 12537358 · Received September 27, 2021

    Report

    Report Number
    1710034-2021-00844
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    August 30, 2021
    Report Date
    October 6, 2021
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD IV CATHETER ADAPTER ASSEMBLY FROM LOT 1040911 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 UNIT AND OBSERVED THAT THE OUTER THREAD AT THE END OF THE LUER ADAPTER WAS SMASHED AND HAD A NICK AT ONE SIDE. THE DAMAGE TO THE OUTER THREADS OF THE LUER COULD PREVENT A CONNECTION TO BE ACHIEVED AND RESULTED IN THE REPORTED LEAKAGE. NEXT, A WATER/AIR LEAK TEST WAS PERFORMED AND LEAKAGE WAS OBSERVED COMING FROM THE DEVICE. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING RELATED DEFECT THAT OCCURRED DUE TO A MISALIGNMENT BETWEEN THE ADAPTER AND THE MANUFACTURING EQUIPMENT. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION WAS ISSUED BY THE MANUFACTURING FACILITY TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER THERE WAS LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER REPORTED ABOUT LEAKAGE OCCURRING FROM THE CONNECTION. NO FURTHER INFORMATION, INCLUDING WHAT LEAKED, HAS NOT BEEN PROVIDED.

    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 WHEN USING THE BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER THERE WAS LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER REPORTED ABOUT LEAKAGE OCCURRING FROM THE CONNECTION. NO FURTHER INFORMATION, INCLUDING WHAT LEAKED, HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430015 BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ 381823 1040911 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1