BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 13698004 · Received March 8, 2022

    Report

    Report Number
    9610048-2022-00018
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 8, 2022
    Report Date
    May 6, 2022
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 19-APR-2022. H6: INVESTIGATION SUMMARY; BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT, 1211735, 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 CATHETER WAS STUCK INSIDE THE NEEDLE GUARD. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THERE WAS A MISALIGNMENT BETWEEN THE CATHETER GUIDANCE AND PLACEMENT STATION THAT CAUSED THE CATHETER TO BECOME STUCK INSIDE. 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¿ SHIELDED IV CATHETER NEEDLE SEPARATED FROM THE HUB WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "WHEN REMOVING THE ABOCATH FROM THE PACKAGING, ONLY THE NEEDLE CAME, AND THE OUTER PORTION (POLYETHYLENE) REMAINED INSIDE THE OUTER PROTECTIVE COVER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE SEPARATED FROM THE HUB WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "WHEN REMOVING THE ABOCATH FROM THE PACKAGING, ONLY THE NEEDLE CAME, AND THE OUTER PORTION (POLYETHYLENE) REMAINED INSIDE THE OUTER PROTECTIVE COVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2760065 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381823 1211735 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown