BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 16959256 · Received May 18, 2023

    Report

    Report Number
    1710034-2023-00529
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    April 27, 2023
    Report Date
    June 30, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903815111
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3: 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, D10: RETURNED TO MANUFACTURER ON: 14-JUN-2023 . H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 6 24GX0.56IN INSYTE AUTOGUARD DEVICES FROM LOT NUMBER 3002689. A GROSS VISUAL INSPECTION SHOWS THAT ONE UNIT IS SEALED IN ITS PACKAGING, (B)(4) UNITS HAVE NEEDLE COVERS OVER THE NEEDLES AND 3 UNITS ARE ONLY CATHETER ASSEMBLIES. NONE OF THE UNITS DISPLAY ANY PHYSICAL DEFECT OR DAMAGE. PER THE REPORT, THE INVESTIGATION WAS PERFORMED FOR A DULL NEEDLE, DIFFICULT THREADING AND DEFECTIVE CATHETER. NONE OF THE PROVIDED CATHETERS WERE FOUND DAMAGED. THE CATHETERS THAT WERE PROVIDED WERE LEAK TESTED AND NONE SHOWED ANY LEAKAGE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAST NIGHT, NICU WENT THRU 3 IV¿S, ONE HAD A CATHETER THAT SPLIT, ONE WOULDN¿T RETHREAD, AND ONE WOULDN¿T PIERCE THE SKIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER SPLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAST NIGHT, NICU WENT THRU 3 IV¿S, ONE HAD A CATHETER THAT SPLIT, ONE WOULDN¿T RETHREAD, AND ONE WOULDN¿T PIERCE THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756677 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3002689 00382903815111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown