BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9454642 · Received December 11, 2019

    Report

    Report Number
    2951238-2019-01213
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    May 19, 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 ADDITIONAL INFORMATION RECEIVED. THE LEGAL MANUFACTURER REVIEWED THE CONTENTS OF THIS COMPLAINT AND PERFORMED A PHOTOGRAPHIC INVESTIGATION USING THE IMAGES PROVIDED IN THE COMPLAINT. THE CUSTOMER¿S COMPLAINT OF A CONTAMINATED VENT TUBE WAS ACKNOWLEDGED THROUGH THE PROVIDED IMAGE AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AND THEREFORE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED. THE LEGAL MANUFACTURER REPORTED THAT THIS WAS A PULL AND PACK ITEM, WHICH WAS SUPPLIED TO THE MANUFACTURING SITE AS BLANK PART NUMBER 9240044 AND DIRECTLY ISSUED FROM CLEAN ROOM STOCK TO BE PACKAGED INTO FINISHED GOOD 240044. A DHR REVIEW WAS PERFORMED THERE WERE TWO LOTS OF 924044 PACKAGED INTO THIS FINISHED GOOD LOT, BLANK LOT NUMBERS 0009752 (482EA.) AND 0009304 (118EA.). THESE LOTS WERE RECEIVED FROM THE SUPPLIER BETWEEN LATE JULY 2018 THRU SEPT. 2018. NO ABNORMALITIES IN WERE NOTED IN THE DHR. A COMPLAINT HISTORY SEARCH FROM OCT-2018¿ FEB-2020 WAS PERFORMED AND FOUND THERE WERE ONLY TWO REPORTED COMPLAINTS OF FOREIGN MATERIAL FOR THIS PRODUCT. THIS EQUATES TO A 0.02% COMPLAINT RATE (2 COMPLAINTS / (B)(4) SHIPPED). (B)(4). THE PFMEA STATES THAT CONTAMINATION WITHIN THE BLUE MOLD COULD BE A RESULT OF A PART NOT CLEANED BEFORE PACKAGING OR FOREIGN MATERIAL IN BLUE MOLD PRIOR TO PACKAGING. THIS IS RATED AS A LOW RISK. THE INSTRUCTIONS FOR USE STATES UNDER HOW SUPPLIED TO INSPECT ALL PACKAGES FOR PUNCTURES OR EVIDENCE OF CONTAMINATION PRIOR TO OPENING, THE PRODUCTS WILL REMAIN STERILE IN AN UNDAMAGED, UNOPENED PACKAGE.

    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. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245471 PAPARELLA-TYPE VENT TUBE, SILICONE .040" (6/PK) PAPARELLA-TYPE VENT TUBE ETD GYRUS ACMI, INC 240044 ME817772

    Patients

    Seq Age Sex Outcome Treatment
    1