BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 12407827 · Received September 1, 2021

    Report

    Report Number
    1710034-2021-00772
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 3, 2021
    Report Date
    October 6, 2021
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-09-13. H6: INVESTIGATION SUMMARY: BD RECEIVED AN 18 GAUGE INSYTE AUTOGUARD BLOOD CONTROL DEVICE FROM LOT 1033709 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 DEVICE AND OBSERVED THAT THE INSIDE OF THE LUER ON THE ADAPTER WAS DAMAGED. NEXT, A LEAK TEST WAS PERFORMED AND LEAKAGE WAS OBSERVED COMING FROM THE DAMAGED LUER. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DURING ASSEMBLY. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER NOT WORKING DURING USE. LEAKAGE. INSTALLATION OF A SECOND CATHETER, BAGGED THE DYSFUNCTIONAL ONE TO BE SENT TO THE SURVEILLANCE DEPARTMENT.

    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 THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER NOT WORKING DURING USE. LEAKAGE. INSTALLATION OF A SECOND CATHETER, BAGGED THE DYSFUNCTIONAL ONE TO BE SENT TO THE SURVEILLANCE DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302187 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ 1033709

    Patients

    Seq Age Sex Outcome Treatment
    1