BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIOMATERIAL

    MDR report key: 15911843 · Received December 2, 2022

    Report

    Report Number
    8041187-2022-00695
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 8, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903812234
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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: 14-DEC-2022. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 35 REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE NO ABNORMALITIES OR DAMAGES. NO ABNORMALITIES OR DAMAGES WERE OBSERVED IN THE SUPPLIED SAMPLE PHOTO AS WELL. THE RETURNED SAMPLES UNDERWENT LEAKAGE TESTING, AND THE SAMPLES SHOWED NO SIGNS OF LEAKAGE. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE DEFECT WAS NOT CONFIRMED. DEVICE HISTORY RECORD OF PACKAGED NEEDLE (PN) BATCH 2022722 CATALOGUE NUMBER 381223 AND ITS ASSEMBLED NEEDLE (AN) BATCHES 2025485 AND 1274263, PART NUMBER YF01223SGT WAS REVIEWED.

    Additional Manufacturer Narrative · 0

    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¿, PERIPHERAL IV CANNULA, BD VIALON¿ WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SOME CATHETERS ARE LEAKING, I.E. ALLOWING BLOOD AND CONTRAST TO PASS THROUGH. NEW INFORMATION RECEIVED: "REGARDING WHAT YOU ASK FOR REASONS I THINK ARE EVIDENT I CANNOT PHOTOGRAPH THE BLOOD COMING OUT OF THE THREAD, I CAN ONLY SAY THAT IT IS AFTER INJECTION OF CONTRAST, THE NUMBER EXACTLY, I DO NOT KNOW BECAUSE WE DO NOT COUNT, WE ARE MORE THAN ONE TECHNICIAN AND IT HAPPENED TO ALL ALWAYS WITH THE SAME (BLUE), WE OPENED THE OTHER BOX AND THEN I CAN GUARANTEE THAT IT HAPPENED TO ME 2X BECAUSE I USE THIS SIZE VERY RARELY. THIS IS THE PLACE WHERE CONTRAST ALMOST ALWAYS COMES OUT. (TALKING ABOUT THE PICTURE, THAT IS MARKED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: SOME CATHETERS ARE LEAKING, I.E. ALLOWING BLOOD AND CONTRAST TO PASS THROUGH. NEW INFORMATION RECEIVED: "REGARDING WHAT YOU ASK FOR REASONS I THINK ARE EVIDENT I CANNOT PHOTOGRAPH THE BLOOD COMING OUT OF THE THREAD, I CAN ONLY SAY THAT IT IS AFTER INJECTION OF CONTRAST, THE NUMBER EXACTLY, I DO NOT KNOW BECAUSE WE DO NOT COUNT, WE ARE MORE THAN ONE TECHNICIAN AND IT HAPPENED TO ALL ALWAYS WITH THE SAME (BLUE), WE OPENED THE OTHER BOX AND THEN I CAN GUARANTEE THAT IT HAPPENED TO ME 2X BECAUSE I USE THIS SIZE VERY RARELY. THIS IS THE PLACE WHERE CONTRAST ALMOST ALWAYS COMES OUT. (TALKING ABOUT THE PICTURE, THAT IS MARKED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946019 BD INSYTE¿, PERIPHERAL IV CANNULA, BD VIALON¿ BIOMATERIAL INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 381223 2022722 30382903812234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown