BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 10889350 · Received November 23, 2020

    Report

    Report Number
    9610048-2020-00161
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    October 27, 2020
    Report Date
    February 7, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD BL 22GA X 1.0IN HAD A SAFETY LOCK ISSUE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY LOCK ISSUES. WHEN PUNCTURING AND TIGHTENING THE LOCK TO REMOVE THE NEEDLE, IT FLOWS BACK ALL THE BLOOD, LEAKING, SO WE HAVE TO HOLD IT MANUALLY AS IT WAS BEFORE, WITHOUT THE LOCK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0161764, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2020-06-24. MEDICAL DEVICE LOT #: 0153092, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2020-06-10. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOGUARD BL 22GA X 1.0IN HAD A SAFETY LOCK ISSUE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY LOCK ISSUES. WHEN PUNCTURING AND TIGHTENING THE LOCK TO REMOVE THE NEEDLE, IT FLOWS BACK ALL THE BLOOD, LEAKING, SO WE HAVE TO HOLD IT MANUALLY AS IT WAS BEFORE, WITHOUT THE LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347592 INSYTE AUTOGUARD BL 22GA X 1.0IN CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381823 SEE H.10 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1