BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IAG BC PRO GLOBAL BLU 22GA X 1.0IN

    MDR report key: 19867517 · Received July 30, 2024

    Report

    Report Number
    1710034-2024-00801
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 4, 2024
    Report Date
    October 31, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TEN INSYTE AUTOGUARD BC PRO GLOBAL 22GA X 1.0IN REPRESENTATIVE UNITS. YOUR REPORT OF DULL NEEDLES, COMPLICATIONS WITH THE RETRACT BUTTON, AND LEAKAGE BEYOND THE SEPTUM COULD NOT BE CONFIRMED FROM THE 10 REPRESENTATIVE SAMPLES. A FUNCTIONAL TEST TO SIMULATE NEEDLE TIP AND CATHETER TIP PENETRATION SHOWED THAT THE MEASURED FORCES WERE WITHIN SPECIFICATION. A FUNCTIONAL TEST OF THE SAFETY MECHANISM SHOWED NO DEFECTS WITH NEEDLE RETRACTION. A LEAK TEST SHOWED THAT THE BLOOD ESCAPE TIME WAS WITHIN SPECIFICATION. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT.

    Description of Event or Problem · 0

    MATERIAL # 381023. BATCH # 4110703. IT WAS REPORTED THAT THE BD IAG BC PRO GLOBAL BLU 22GA X 1.0IN NEEDLE RETRACTION WAS SLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE JUST TRIED USING THIS LOT # AS WELL, LOT # 4110703 AND THE STAFF HERE ARE STILL EXPERIENCE THE SAME ISSUES AS WITH LOT # 381023, CAN YOU ADD LOT # 4110703 TO THIS COMPLAINT. THE NURSING STAFF ARE COMPLAINING OF ISSUES WITH THESE IV CATHETERS 22 GUAGE THE ISSUES ARE NOT WITH EVERY IV CATHETER BUT WITH MANY OF THEM. LATELY, THE NEEDLES ARE DULL AND HARD TO PUT INTO THE PATIENTS SKIN, THE RETRACT BUTTON IS HARD TO PUSH AND BLOOD AUTOGUARD DOESN'T ALWAYS HOLD THE BLOOD BACK UNTIL THE IV LINE IS CONNECTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254702 BD IAG BC PRO GLOBAL BLU 22GA X 1.0IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4110703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown