BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 18565946 · Received January 23, 2024

    Report

    Report Number
    1710034-2024-00025
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 4, 2024
    Report Date
    March 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED 3 PHOTOS AND ONE UNIT OF A 24GX0.75IN INSYTE AUTOGUARD DEVICE FROM LOT 3121182 FOR THE INVESTIGATION OF THIS COMPLAINT. INSPECTION OF THE PHOTOS SHOWS A UNIT WITH THE NEEDLE PARTIALLY RETRACTED WITHOUT THE CATHETER PRESENT. A GROSS VISUAL INSPECTION OF THE PHYSICAL SAMPLE RESEMBLED THE UNIT FROM THE PHOTOGRAPHS. PHYSICAL SAMPLE: CLOSER OBSERVATION SHOWS THAT THE SHIELD (GRIP/BARREL) THAT HOUSES THE NEEDLE IS DAMAGED. THE DAMAGE APPEARS TO BE FLASH OR DENT AT THE INTERFACE BETWEEN THE GRIP AND BARREL THAT RESTRICTS THE INNER DIAMETER (ID) OF THE SHIELD. THE NEEDLE WAS RE-ENGAGED AND UPON PRESSING THE SAFETY BUTTON, THE NEEDLE HUB GOT STUCK AT THE DAMAGED AREA OF THE SHIELD. THE DAMAGE ON THE SHIELD EXHIBITED NO MARKS OR IMPRESSIONS THAT WOULD INDICATE PHYSICAL FORCE WAS APPLIED FROM THE EXTERNAL SURFACE OF THE UNIT. THE CUSTOMER REPORTED DEFECT OF FAILURE TO FULLY RETRACT WAS CONFIRMED AND WAS CODED AS 'NEEDLE SHIELDING FAILURE'. THE DEFECT OF NEEDLE SHIELDING FAILURE IS LIKELY DUE TO THE DAMAGE THAT CAN BE SEEN ON THE BARREL. THE DAMAGE APPEARED TO BE ON THE GRIP AND COULD OCCUR DUE TO MISALIGNMENT WHILE PLACING THE BARREL ON TOP OF THE GRIP. IN ADDITION, THE DEVICE DOES NOT EXHIBIT EVIDENCE OF EXTERNAL PHYSICAL DEFECTS, SUGGESTING THAT DAMAGE FROM THE USER ENVIRONMENT WAS UNLIKELY. PHOTO SAMPLE: THE HUB APPEARS TO ALSO BE STUCK AT THE EXACT SAME LOCATION AS WITH THE PHYSICAL SAMPLE. THE LOCATION WHERE IT IS STOPPED APPEAR CLOUDY AS IF IT IS THE LOCATION OF THE DAMAGE THAT WAS OBSERVED ON THE PHYSICAL SAMPLE. THIS DAMAGE AS DESCRIBED ON THE PHYSICAL SAMPLE ANALYSIS IS MANUFACTURING RELATED AND IT IS LIKELY THE CAUSE OF THE PARTIAL RETRACTION. OPERATORS PERFORM FUNCTIONAL TESTING, VISUAL INSPECTIONS, AND SETUP/SETUP VERIFICATION PER THE QUALITY PLAN TO MITIGATE THIS TYPE OF DEFECT. ADDITIONALLY, PREVENTATIVE MAINTENANCE (PM) IS PERFORMED TO ENSURE PROPER FUNCTIONING OF THE EQUIPMENT. INVESTIGATION CONCLUSION(S): THE DEFECT OF ¿FAILURE TO RETRACT¿ IS CONFIRMED. "NEEDLE SHIELDING FAILURE" WAS USED AS THE AS ANALYZED CODE SINCE THE NEEDLE WAS PARTIALLY RETRACTED. PROBABLE ROOT CAUSE CONCLUSION(S): MANUFACTURING THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT.

    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

    IT WAS REPORTED THAT A BD INSYTE AUTOGUARD BC PRO GLOBAL YEL 24GA X .75IN HAD DIFFICULTY RETRACTING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A COMPLAINT ABOUT SAFETY MECHANISM DOES NOT WORK. ACCORDING TO THE CUSTOMER REPORT THE NEEDLE DOES NOT RETRACT INTO THE CASE WHEN THE SAFETY MECHANISM ACTIVATION BUTTON IS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849215 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3121182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown