BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002807968-2017-00048

    MDR report key: 7141522 · Received December 22, 2017

    Report

    Report Number
    3002807968-2017-00048
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 5, 2017
    Report Date
    October 3, 2018
    PMA / PMN Number
    K962158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE INVESTIGATION: THE ROOT CAUSE OF CORROSION IS EXPOSURE TO HIGH CONCENTRATIONS OF CHLORIDE CONTAINING GAS/LIQUID IN A HIGH TEMPERATURE AND 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. LITERATURE INVESTIGATION AND EXPERTS STATEMENTS. BY TESTING OF REFERENCE SAMPLES, IT HAS BEEN CONCLUDED THAT EXPOSURE TO CHLORIDE OCCURS AFTER SAMPLERS HAVE BEEN SHIPPED TO (B)(6). 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. 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.

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT, THE SURFACE OF THE NEEDLE ON A PICO70 SAMPLER IS REPORTED AS BEING RUSTY. NONE OF THE PICO70 SAMPLERS WITH RUST ON HAS BEEN USED ON PATIENTS, ALL PICO70 ARE STILL IN SEALED PACKAGING.

    Patients

    Seq Age Sex Outcome Treatment
    1