BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICO70

    MDR report key: 10695401 · Received October 19, 2020

    Report

    Report Number
    3002807968-2020-00044
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 13, 2020
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    JKA
    UDI-DI
    05700699565334
    PMA / PMN Number
    K962158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020 RADIOMETER DECIDED TO RECALL THE AFFECTED LOT (HU50) FROM CHINA. ROOT CAUSE INVESTIGATION HAS CONFIRMED THAT THE ROOT CAUSE IS THE SAME AS FOR PREVIOUS SIMILAR INCIDENTS REPORTED FROM CHINA. THE ROOT CAUSE OF CORROSION IS EXPOSURE TO HIGH CONCENTRATIONS OF CHLORIDE CONTAINING GAS/LIQUID IN A HIGH TEMPERATURE & HIGH HUMIDITY ENVIRONMENT. ANALYSIS AND INVESTIGATIONS HAVE BEEN MADE TO SUPPORT THIS ROOT CAUSE: - CHLORIDE SALTS IDENTIFIED ON SYRINGES. - FEO + FECL3 IDENTIFIED ON CORRODED NEEDLES. - SIGNIFICANT SMELL OF CHLORIDE OF SAMPLERS WITH CORRODED NEEDLES. BY TESTING OF REFERENCE SAMPLES, IT HAS BEEN CONCLUDED THAT EXPOSURE TO CHLORIDE OCCURS AFTER SAMPLERS HAVE BEEN SHIPPED TO CHINA. - INVESTIGATION OF EACH STEP OF THE SUPPLY CHAIN HAS BEEN PERFORMED. - USE OF CHLORIDE CONTAINING GASES HAS NOT BEEN IDENTIFIED ANYWHERE IN THE SUPPLY CHAIN AND WOULD NOT BE PRESENT DURING NORMAL HANDLING/STORAGE/SHIPPING. HENCE, SAMPLERS FROM THE SAME LOT OUTSIDE OF CHINA WILL NOT BE AFFECTED . CONCLUSION IS THAT NO SYSTEMATIC PATTERN OF NEEDLE CORROSION CAN BE FOUND. THE CORROSION IS LIMITED TO A FEW NEEDLES OF EACH LOT, AND WILL NOT BE PRESENT DURING INTENDED HANDLING, STORAGE AND SHIPPING. THERE HAVE BEEN NO REPORTS OF PATIENT HARM. THERE HAVE BEEN NO REPORTS OF CORRODED NEEDLES FROM ANY OTHER COUNTRY THAN CHINA.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THERE IS NEEDLE CORROSION ON 11 PICO70 BLOOD SAMPLERS FROM THE SAME BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166395 PICO70 PICO70 JKA RADIOMETER MEDICAL APS 956-533 956-533HU50 05700699565334

    Patients

    Seq Age Sex Outcome Treatment
    1