BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 10978715 · Received December 9, 2020

    Report

    Report Number
    1710034-2020-00788
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 12, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED THIRTY-FOUR UNUSED UNITS IN SEALED PACKAGES FROM MATERIAL NUMBER 381923, LOT NUMBER 0132284 AND TWO PHOTOS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. DURING THE VISUAL EXAMINATION IT WAS OBSERVED THAT THE PERFORATED SLIT BETWEEN THE PAIRED PACKAGES WAS PRESENT ON THE TOP WEB BUT DID NOT GO THROUGH TO THE BOTTOM WEB. THE PAIRED PACKAGES WERE ATTEMPTED TO BE PULLED APART, BUT THEY WOULD NOT EASILY SEPARATE CONFIRMING THE REPORTED DEFECT. BASED ON THE APPEARANCE OF THE DEFECT, THE ROOT CAUSE IS LIKELY DUE TO LOW CUTTING PRESSURE DURING THE PERFORATION STEP OF THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD BL 22GA X 1.0IN CUT LINE IS NOT EASY TO TEAR. THIS OCCURRED ON 32 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUTTING LINE IS NOT EASY TO TEAR.

    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. FDA DEVICE PROBLEM CODE: 3007, FDA PATIENT PROBLEM CODE: 2645.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOGUARD BL 22GA X 1.0IN CUT LINE IS NOT EASY TO TEAR. THIS OCCURRED ON 32 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUTTING LINE IS NOT EASY TO TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439430 INSYTE AUTOGUARD BL 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381823 0132284 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1