BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC

    MDR report key: 9333171 · Received November 16, 2019

    Report

    Report Number
    1710034-2019-01230
    Event Type
    Malfunction
    Date Received
    November 16, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED 5 UNUSED INSYTE AUTOGUARD BLOOD CONTROL 20 GAUGE UNITS FROM LOT 9193596 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 INSPECTED THE RETURNED UNITS UNDER A MICROSCOPE AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE. NEXT, AN ARTIFICIAL VEIN WAS USED TO TEST FOR VENIPUNCTURE. EACH UNIT PERFORMED SUCCESSFULLY. NO ISSUES WERE FOUND DURING TESTING. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND DURING INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC HAS BEEN FOUND DAMAGED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CATHETER WOULD NOT SEPARATE FROM THE NEEDLE AND THE CATHETER BROKE. PER EMAILS: I HAD AN INCIDENT TONIGHT WHEN PLACING AN IV, THE CATHETER WOULDN'T SEPARATE FROM THE NEEDLE. I REMOVED THE CATHETER AND THE NEEDLE AND THERE WAS A BREAK IN THE CATHETER ITSELF. ONE OF THE CT TECHS SAID SOMETHING SIMILAR HAPPENED TO HER THIS WEEK AS WELL INJURIES OR ADVERSE EVENT: NO. ITEM: 382533. QUANTITY AFFECTED: 1 BX.. LOT NUMBER: 9193596.

    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 HAS BEEN REPORTED THAT ONE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC HAS BEEN FOUND DAMAGED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CATHETER WOULD NOT SEPARATE FROM THE NEEDLE AND THE CATHETER BROKE. PER EMAILS: I HAD AN INCIDENT TONIGHT WHEN PLACING AN IV, THE CATHETER WOULDN'T SEPARATE FROM THE NEEDLE. I REMOVED THE CATHETER AND THE NEEDLE AND THERE WAS A BREAK IN THE CATHETER ITSELF. ONE OF THE CT TECHS SAID SOMETHING SIMILAR HAPPENED TO HER THIS WEEK AS WELL INJURIES OR ADVERSE EVENT: NO. ITEM: 382533 . QUANTITY AFFECTED: 1 BX. LOT NUMBER: 9193596.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126962 BD¿ 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9193596 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other