BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ VIALON E IV CATHETER

    MDR report key: 13830358 · Received March 20, 2022

    Report

    Report Number
    8041187-2022-00132
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    December 29, 2021
    Report Date
    March 11, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0269949. MEDICAL DEVICE EXPIRATION DATE: 2025-09-30 . DEVICE MANUFACTURE DATE: 2020-09-25. MEDICAL DEVICE LOT #: 9142939. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-05-22. INVESTIGATION SUMMARY: SIX PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTOS AND SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR CATHETER TIP DAMAGE. THE SAMPLE, FROM BATCH 0269949, A ¿V-CUT¿ WAS OBSERVED NEAR THE CATHETER TIP. THE SAMPLE, FROM BATCH 9142939, WAS OBSERVED WITH A MINOR TIP SPEAR ON THE CATHETER TIP. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE OBSERVED DEFECT COULD BE CAUSED BY THE NEEDLE PIERCED THROUGH THE CATHETER. THE ASSEMBLY PROCESS WAS REVIEWED. IF THE NEEDLE PIERCED THROUGH CATHETER OCCURRED IN THE MANUFACTURING PROCESS, THE DEFECT WOULD BE DETECTED AND AUTO REJECTED BY THE 100% INLINE TIP SPEAR VISION INSPECTION SYSTEM. NEEDLE PIERCED THROUGH CATHETER COULD ALSO HAPPEN DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED. AS THE SAMPLES WERE OBSERVED IN OPEN PACKAGING, THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING CONTROLS HAVE BEEN PUT IN PLACE TO PREVENT AND DETECT THE NEEDLE BEING PIERCED THROUGH CATHETER FROM OCCURRING: THE VISION SYSTEM CAMERA IS NOT OUT OF FOCUS WHEN CAPTURING THE DEFECT BY USING VARIOUS METAL BLOCKS FOR DIFFERENT GAUGES TO PREVENT THE VISION ASSEMBLY FROM DROPPING UNDER ITS WEIGHT AND THE CATHETER IS ALIGNED TO ONE SIDE USING VACUUM TO AID THE INSERTION OF THE CANNULA THUS REDUCING THE LIKELIHOOD OF THIS NONCONFORMANCE FROM OCCURRING. A DAILY CHALLENGE OF THE VISION SYSTEM IS PERFORMED, AND VISUAL INSPECTION IS PERFORMED DURING OUTGOING INSPECTION. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSYTE¿ VIALON E IV CATHETER EACH FROM LOTS 0269949 AND 9142939 HAD DAMAGED TIPS, WITH THE V-CUT IN THE 0269949 CATHETER BEING INDICATIVE OF THE NEEDLE PIERCING THROUGH IT WHILE INTRODUCING IT TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "ACCORDING TO THE CUSTOMER'S REPORT, AFTER CATHETER PLACEMENT, THE HCP ADVANCED THE CATHETER BUT FELT STRONG RESISTANCE AND COULD NOT ADVANCE IT ANY FURTHER." VIA BD INVESTIGATION: "THE SAMPLE, FROM BATCH 0269949, A ¿V-CUT¿ WAS OBSERVED NEAR THE CATHETER TIP. THE SAMPLE, FROM BATCH 9142939, WAS OBSERVED WITH A MINOR TIP SPEAR ON THE CATHETER TIP... THE OBSERVED DEFECT COULD BE CAUSED BY THE NEEDLE PIERCED THROUGH THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515730 BD INSYTE¿ VIALON E IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown