BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAPARELLA-TYPE VENT TUBE, SILICONE .040" (6/PK)

    MDR report key: 9454646 · Received December 11, 2019

    Report

    Report Number
    2951238-2019-01214
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    April 22, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    ETD
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW. DHR REVIEW WAS PERFORMED. DHR FOR THE FINISHED DEVICE WAS REVIEWED AND NO ABNORMALITIES IN DOCUMENTATION OR PROCESS WAS FOUND.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED A SINGLE PIECE OF THE 240044 PAPARELLA-TYPE VENT TUBE, SILICONE FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RECEIVED CONDITION OF THE VENT TUBE AND DISCOVERED DEBRIS AND LINT THROUGHOUT THE DEVICE. THE SINGLE VENT TUBE WAS RECEIVED INSIDE OF A BLUE CONTAINER (NO DAMAGE), PACKAGED INSIDE THE ORIGINAL BOX (WHICH WAS OPEN). HOWEVER, THE STERILE PACKAGE WAS NOT RECEIVED AND THEREFORE, COULD NOT BE INSPECTED SINCE IT WAS NOT RETURNED FOR EVALUATION. THE INNER DIAMETER OF THE DEVICE WAS MEASURED ACCORDING TO THE INFORMATION PROVIDED IN THE MANUAL; THE INNER DIAMETER IS APPROXIMATELY 1.02MM WHICH WAS MEASURED USING THE CALIPER. BASED ON THE EVALUATION, THE DEBRIS AND LINT FOUND ON THE DEVICE LIKELY OCCURRED AFTER REMOVING THE VENT TUBE FROM THE PACKAGE.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED BY THE CUSTOMER THERE IS A LOT OF DEBRIS AND EXTRA PLASTIC ON THE PAPARELLA-TYPE VENT TUBE, THE DEBRIS IS WHITE IN COLOR. THE USER FACILITY REPORTED THAT THE TUBES WERE IMPLANTED INTO TWO PATIENTS AND WERE WIPED AND SOAKED IN SALINE PRIOR TO IMPLANTING. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER HAS ONE PIECE LEFT AND THE DOCTORS DO NOT WANT TO IMPLANT IT INTO CHILDREN'S EARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245678 PAPARELLA-TYPE VENT TUBE, SILICONE .040" (6/PK) PAPARELLA-TYPE VENT TUBE, SILICONE ETD GYRUS ACMI, INC 240044 ME817772

    Patients

    Seq Age Sex Outcome Treatment
    1