BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 16925060 · Received May 12, 2023

    Report

    Report Number
    1710034-2023-00509
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 20, 2023
    Report Date
    June 1, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 25-APR-2023 INVESTIGATION SUMMARY BD RECEIVED 37 INSYTE AUTOGUARD 22 GAUGE DEVICES FROM LOT 2243842 FOR EVALUATION. THREE OF THE DEVICES WERE NOTED TO BE RECEIVED IN OPENED PACKAGING WHILE THE REMAINING 34 WERE STILL INSIDE OF THEIR SEALED PACKAGING. 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 UNITS AND OBSERVED NO PHYSICAL DEFECTS OR DEFORMITIES. NEXT, THE SEALED UNITS WERE INSPECTED THE TIP ADHESION AND CATHETER THREADING BUT NO ISSUES WERE FOUND. THE ENGINEER DETERMINED THAT THE SEALED UNITS WERE FULLY FUNCTIONAL AND MET PRODUCT SPECIFICATIONS. FINALLY, THE OPENED UNITS WERE MICROSCOPICALLY INSPECTED FOR ANYTHING THAT COULD HAVE CAUSED THE REPORTED ISSUES AS WELL BUT NO DEFECTS WERE FOUND. THEREFORE, BASED OFF THE VISUAL/MICROSCOPIC INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. THE RETURNED UNITS ALL APPEARED TO BE FUNCTIONAL AND WITHIN PRODUCT SPECIFICATIONS. SINCE NO DEFECTS WERE FOUND DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    B.3. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER HUB WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD HAVE TO DEFER TO HIM TO ELABORATE ON THE ISSUE WITH THEM STICKING. ON THE 22 GA THE BLUE HUB STICKS TO THE CATHETER BASE. IT IS CLEARLY EVIDENT WITH THE ONES I SENT TO OMIT. THE BLUE HUB IS BONDED TO THE CLEAR PLASTIC BASE THESE HAVE NOT BEEN USABLE UNLESS WE RELEASE THEM PRIOR TO STICKING THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER HUB WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD HAVE TO DEFER TO HIM TO ELABORATE ON THE ISSUE WITH THEM STICKING. ON THE 22 GA THE BLUE HUB STICKS TO THE CATHETER BASE. IT IS CLEARLY EVIDENT WITH THE ONES I SENT TO OMIT. THE BLUE HUB IS BONDED TO THE CLEAR PLASTIC BASE THESE HAVE NOT BEEN USABLE UNLESS WE RELEASE THEM PRIOR TO STICKING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043928 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2243842 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown