BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 19606045 · Received June 25, 2024

    Report

    Report Number
    3002601200-2024-00271
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 2, 2024
    Report Date
    August 7, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 4052011. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 4052011. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC CATHETER SPLITTING / CRACKED / SHEARING / FRAYED AT 09:30 ON (B)(6) 2024, THE NURSE TEACHER OF THE SECOND OBSTETRICS WARD INSERTED THE NEEDLE INTO THE PATIENT'S VEIN. AFTER PENETRATING THE SKIN AND REACHING THE BLOOD VESSEL, THE PATIENT COMPLAINED THAT THE PAIN WAS OBVIOUSLY UNBEARABLE. THE NURSE IMMEDIATELY PULLED OUT THE INDWELLING NEEDLE. AFTER INSPECTION, IT WAS FOUND THAT THE FRONT END OF THE INDWELLING NEEDLE WAS SEPARATED FROM THE HOSE, AND THE INDWELLING NEEDLE SHOULD BE REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442027 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052011 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown