BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 14976444 · Received July 11, 2022

    Report

    Report Number
    1710034-2022-00358
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 13, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE SEALED 20 GA X 1.16 IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 1299616. ADDITIONALLY, THREE PHOTOS WERE RECEIVED. A VISUAL INSPECTION DISCOVERED THAT THERE WAS BROWN LOOSE MATTER INSIDE THE PACKAGE AND SOME BLACK INK. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE PACKAGING PROCESS. THE LOOSE FOREIGN MATERIAL MAY HAVE BEEN INTRODUCED DURING PACKAGING OR MANUFACTURING AS A RESULT OF ENVIRONMENTAL FACTORS, INCOMING MATERIAL, OR PERSONNEL. TO MITIGATE THE OCCURRENCE OF THESE DEFECTS: OPERATORS PERFORM CLEANING PER THE QUALITY PLAN AND THE BD 5S INITIATIVE, GOOD MANUFACTURING PRACTICES AND GOWNING ARE FOLLOWED, AND ENVIRONMENTAL CONTROLS AND INSPECTIONS FOR FOREIGN MATTER ARE PERFORMED PER THE QUALITY CONTROL AND SAMPLING PLANS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD FOREIGN MATTER ON THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM (B)(6). "UNDER STERILIZED CONDITIONS IN THE OP ROOM, A BROWN FM ON THE NEEDLE COVER TIP WAS FOUND BEFORE USE.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD FOREIGN MATTER ON THE NEEDLE COVER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE . UNDER STERILIZED CONDITIONS IN THE OP ROOM, A BROWN FM ON THE NEEDLE COVER TIP WAS FOUND BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057390 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 1299616 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown