BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿

    MDR report key: 15996994 · Received December 16, 2022

    Report

    Report Number
    3003916417-2022-00292
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 26, 2022
    Report Date
    February 10, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FOZ
    UDI-DI
    30382903818342
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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: D10: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 27-JAN-2023. H6: INVESTIGATION SUMMARY : BD RECEIVED A 20 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 2012529 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 NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING. THE DEVICE ALSO APPEARED TO HAVE BEEN USED INDICATING THAT THIS MIGHT HAVE OCCURRED AFTER INITIAL USE. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, THE ENGINEER WAS UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE FOR THIS DEFECT. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER, IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DURING THE PUNCTURE THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON, PERIPHERAL VENOUS CATHETER N 20FR, BD, BATCH 2012529, V 12/30/2024, MATERIAL SAVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER, IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DURING THE PUNCTURE THERE WAS VENOUS RUPTURE, WHEN REMOVING THE CATHETER IT WAS VERIFIED THAT THERE WAS TRANSFIXATION OF THE NEEDLE IN THE CANNON, PERIPHERAL VENOUS CATHETER N 20FR, BD, BATCH 2012529, V 12/30/2024, MATERIAL SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152134 BD INSYTE¿ AUTOGUARD¿ INTRAVASCULAR CATHETER FOZ BECTON DICKINSON IND. CIRURGICAS LTDA 381834 2012529 30382903818342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown