BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 7486098 · Received May 4, 2018

    Report

    Report Number
    1820334-2018-01201
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Report Date
    August 6, 2018
    Manufacturer
    COOK INC
    Product Code
    KNT
    UDI-DI
    00827002084179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: OPERATOR OF DEVICE:QUALITY CONTROL-DISTRIBUTOR. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL AND A VISUAL INSPECTION/DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE UNOPENED RETURNED DEVICE CONFIRMED THE PRESENCE OF FOREIGN MATTER ENCLOSED WITHIN THE OUTER POUCH. THE DEVICE IS OUT OF SPECIFICATION PER QUALITY CONTROL DOCUMENTS - FOREIGN MATTER. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THEREFORE, THERE IS NO EVIDENCE TO SUGGEST ALL ITEMS IN THE LOT OR SIMILAR DEVICES IN HOUSE OR IN THE FIELD ARE NON-CONFORMING/DEFECTIVE. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE ACTUAL ROOT CAUSE WAS FOUND TO BE MANUFACTURING RELATED. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    BRAND NAME: ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET. (B)(4). PMA/510(K) #: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET WAS RETURNED TO THE DISTRIBUTOR DUE TO A HAIR BEING FOUND INSIDE THE PACKAGE TWO WEEKS PRIOR BY QUALITY CONTROL. THE REPORTED FOREIGN MATTER WAS DISCOVERED BEFORE USE; THEREFORE, NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328451 KNT TUBES, GASTROINTESTINAL KNT COOK INC 00827002084179

    Patients

    Seq Age Sex Outcome Treatment
    1