BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNT TUBES, GASTROINTESTINAL

    MDR report key: 7313565 · Received March 5, 2018

    Report

    Report Number
    1820334-2018-00435
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 8, 2018
    Report Date
    May 30, 2018
    Manufacturer
    COOK INC
    Product Code
    KNT
    UDI-DI
    00827002084179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION/DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE PRESENCE OF A FOREIGN METAL CLIP IN THE SEALED BAG, WHICH IS NOT A COMPONENT THAT SHOULD BE PACKAGED WITH THE DEVICE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE RELEVANT MANUFACTURING DOCUMENTS WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE IS MANUFACTURING RELATED. RETRAINING WAS REQUESTED AND PERFORMED FOR THE RELEVANT DEPARTMENTS. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET. 510K STATUS: PREAMENDMENT. (B)(4). 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

    THE CUSTOMER REPORTED THAT A FOREIGN OBJECT WAS DISCOVERED INSIDE OF THE PACKAGING OF THE ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET. THE OBJECT REPORTEDLY PUNCTURED THE PACKAGING AS WELL. THE DEVICE DID NOT MAKE CONTACT WITH ANY PATIENT; ACCORDING, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, BUT THE INVESTIGATION IS STILL PENDING AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156230 KNT TUBES, GASTROINTESTINAL KNT COOK INC N/A 00827002084179

    Patients

    Seq Age Sex Outcome Treatment
    1