BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTER II

    MDR report key: 2434263 · Received January 12, 2012

    Report

    Report Number
    2028837-2011-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    CALIFORNIA MEDICAL LABORATORIES, INC.
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: ATY: 1. SUMMARY: DEVICE WAS DECONTAMINATED UPON RECEIPT. DEVICE WAS RETURNED ALONG WITH TIP, WHICH HAD BEEN RETRIEVED FROM PT CHEST CAVITY. BOND AREA OF DISTAL TIP WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION. STAINLESS STEEL TUBING SHOWED NO TRACES OF ADHESIVE. TUBING WAS MEASURED TO VERIFY THAT NO BREAKAGE OCCURRED. DISTAL TIP SHOWED MINIMAL TRACES OF ADHESIVE. NO OTHER DAMAGE TO DEVICE COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    TIP OF DEVICE FELL OFF INTO PT CHEST CAVITY. TIP WAS ABLE TO BE RETRIEVED WITHOUT PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MISTER II LAVAGE, JET FQH CALIFORNIA MEDICAL LABORATORIES, INC. MT-22210 S112145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other