BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 11489885 · Received March 15, 2021

    Report

    Report Number
    9610048-2021-00032
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 15, 2021
    Report Date
    May 2, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/15/2021. H.6. INVESTIGATION: BD RECEIVED A 20 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 240078 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 SAMPLE HAD DAMAGE AT THE GRIP, WHICH MAY HAVE CAUSED THE REPORTED DEFECT. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED ISSUE. IT WAS DETERMINED THAT THE OBSERVED DAMAGE TO THE GRIP CAUSED THE FAILED RETRACTION. THIS DAMAGE MOST LIKELY OCCURRED BECAUSE OF A MISALIGNMENT OF THE PLUG PLACEMENT RODS DURING PRODUCTION AND CAUSED A COLLISION WITH THE GRIP. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD PNK 20GA X 1.16IN NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY SYSTEM FAILURE - AFTER THE USE, WHEN ACTIVATING THE SAFETY SYSTEM, THE DEVICE DIDN'T WORK, LETTING THE NEEDLE EXPOSED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WAS REPORTED THAT INSYTE AUTOGUARD PNK 20GA X 1.16IN NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY SYSTEM FAILURE - AFTER THE USE, WHEN ACTIVATING THE SAFETY SYSTEM, THE DEVICE DIDN'T WORK, LETTING THE NEEDLE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376815 INSYTE AUTOGUARD PNK 20GA X 1.16IN CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381834 0240078 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1