BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLN PNCL BTN MOD BLD HLSTR

    MDR report key: 9267270 · Received November 1, 2019

    Report

    Report Number
    1721194-2019-00131
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    August 29, 2019
    Report Date
    October 7, 2019
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559101674
    PMA / PMN Number
    K965054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: 2 EACH 0037H LOT 191107 IN UNOPENED POUCHES WERE RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION OF FIRST SAMPLE FOUND A BROWN EMBEDDED CONTAMINATE ON THE OUTER EDGE OF THE HOLSTER WHICH EXCEEDS SPECIFICATION OF 0.40 MM2. SECOND SAMPLE NO CONTAMINATION/PARTICULATE FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FOREIGN MATTER IN THE PACKAGE. IT WAS ALSO REPORTED THAT THE PACKAGE WAS DAMAGED. THE DEVICES WERE NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059519 E-Z CLN PNCL BTN MOD BLD HLSTR E-Z CLEAN PENCIL BTN MOD BLADE HOLSTER GEI MEGADYNE MEDICAL PRODUCTS, INC. 191107 10614559101674

    Patients

    Seq Age Sex Outcome Treatment
    1