BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING PNK 20GA X1.16IN

    MDR report key: 18642006 · Received February 5, 2024

    Report

    Report Number
    1710034-2024-00072
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 30, 2024
    Report Date
    April 25, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826346
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED ONE PHOTO AND 1 BROKEN CATHETER ADAPTER OF A 20GX1.00IN INSYTE AUTOGUARD DEVICE FROM LOT 3251063 FOR THE INVESTIGATION OF THIS COMPLAINT. THE RETURNED PHOTO SHOWS A STATLOC DEVICE AND THE 20G OAG IS NOT VISIBLE. A GROSS VISUAL INSPECTION SHOWS THE CATHETER ADAPTER IS BROKEN RIGHT ON THE PUSH TAB AROUND THE CIRCUMFERENCES OF THE WASHER. BOTH ENDS WITH THE DAMAGES ARE ROUGH AS THOUGH THE DEFECT WAS CAUSED BY APPLYING SOME FORCE ON THE UNIT. THE TYPE OF DAMAGE OBSERVED IS MOST COMMONLY OBSERVED IN A U-SHAPE AROUND THE ADAPTER. IF EXISTING CRACK IS PRESENT, THE ADAPTER COULD COME INTO 2 PIECES DURING USE. BASED ON THE LOCATION AND SHAPE OF THE CRACK, THE OBSERVED DEFECT MOSTLY LIKELY ORIGINATED DURING THE ZONE FIVE MANUFACTURING PROCESS. MISALIGNMENT OF THE ROTATING GRIPERS WITH RESPECT TO THE PICK AND PLACE GRIPPERS CAN CAUSED A CRACKED ADAPTER. THE MISALIGNMENT WOULD CAUSE CONTACT BEFORE THE ADAPTER ROTATE OPERATION IS COMPLETED. VISUAL INSPECTIONS FOR DAMAGED/CRACKED ADAPTERS AND LEAK TESTING ARE PERFORMED PERIODICALLY PER THE SAMPLING PLAN TO MITIGATE THE RISK OF THIS DEFECT. PREVENTATIVE MAINTENANCE (PM¿S) IS ALSO PERFORMED PERIODICALLY TO ENSURE PROPER FUNCTIONING OF THE EQUIPMENT. THE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. INVESTIGATION CONCLUSION(S): THE DAMAGE OF CATHETER DEFECTIVE/DAMAGE WAS CONFIRMED. PROBABLE ROOT CAUSE CONCLUSION(S): MANUFACTURING.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    ADDITIONAL INFORMATION: 1) WAS THERE A BREAK IN THE METAL NEEDLE CANNULA? NO. 2) WAS THERE A BREAK IN THE IV CATHETER (HOSE)? NO. 3) WAS THERE A CRACK IN THE LUER CONNECTOR OF THE IV CATHETER? THE CRACK IS IN THE NECK OF THE IV CATHETER JUST BEFORE IT NARROWS DOWN TO THE "HOSE". 4) DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? YES, IT WAS INSIDE THE PT AND THE NURSE HAD REMOVED THE NEEDLE, ATTACHED A PIGTAIL AND BLOOD KEPT RUNNING OUT SO SHE DISCOVERED THE CRACK. 5) PLEASE CONFIRM THE NUMBER OF OCCURRENCES. THIS SPECIFIC INCIDENT HAS OCCURRED ONCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING PNK 20GA X1.16IN CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE END OF CANNULA CRACKED CAUSING LEAKING OF BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906178 BD INSYTE AUTOG BC WING PNK 20GA X1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3251063 00382903826346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown