BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) INSYTE VIALON E

    MDR report key: 8922314 · Received August 22, 2019

    Report

    Report Number
    8041187-2019-00669
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT IS UNCONFIRMED AS NO PHOTO / SAMPLES RECEIVED. THE INVESTIGATION WAS NOT ABLE TO CONFIRM WHAT THE CUSTOMER HAD EXPERIENCE AS THERE WERE NO RETURNED SAMPLES/PICTURES FOR EVALUATION. THERE WAS NO QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED NON ¿ CONFORMANCE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE 24G X 0.75IN (0.7 X 19 MM) INSYTE VIALON E HAS BEEN FOUND DEFORMED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN USING ON HCV PATIENT, THE CATHETER WAS BURR.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE 24G X 0.75IN (0.7 X 19 MM) INSYTE VIALON E HAS BEEN FOUND DEFORMED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN USING ON HCV PATIENT, THE CATHETER WAS BURR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717625 24G X 0.75IN (0.7 X 19 MM) INSYTE VIALON E INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8360629

    Patients

    Seq Age Sex Outcome Treatment
    1 Other