BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE

    MDR report key: 3162136 · Received May 31, 2013

    Report

    Report Number
    1820334-2013-00227
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    COOK, INC.
    Product Code
    KNT
    PMA / PMN Number
    K043203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES TO PATIENT WERE NOTED. (B)(4) - MIGRATION IS NOT LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DATE (B)(6) 2013: THEY PLACE THE TIGER PROBE. DATE (B)(6) 2013: PATIENT'S HEALTH DEGRADATION, THE REALIZED ON AN ABDOMINAL SCAN WHICH SHOWED A MIGRATION OF THE PROBE IN "D3" WITH SMALL INTESTINE PERFORATION (PERITONITIS). PATIENT HAD AN EMERGENCY SURGERY, BY LAPAROTOMY: STITCHES, ANASTOMOSIS, PERITONEAL LAVAGE. THEY THREW THE DEVICE AWAY. AS PER COMPLAINT FORM: "MIGRATION OF PROBE 'D3' WITH SMALL INTESTINE PERFORATION (PERITONITIS). ON (B)(6): TIGER2 IS INSERTED, WITH X-RAYS AT EACH STEP: GOOD PROGRESSION AND GOOD POSITIONING. WHEN FINAL POSITION IS OBTAINED, FINAL X-RAYS AND ABDOMINAL SCANNER: ALL IS OK. ON (B)(6): SEPTIC SHOCK DUE TO ACUTE PNEUMOPATHY; CLINICAL AUSCULTATION, ABDOMINAL SCAN, NOSE MARKING CONFIRMED. ON (B)(6): INTRA-ABDOMINAL PRESSURE INCREASE. POST INCIDENT ANALYSIS: THERE WAS ALREADY PERITONITIS CLEWS SHOWN IN THE X-RAYS/ SCANNER (B)(6), THE DEVICE HAD ALREADY MOVED. BETWEEN (B)(6), PATIENT HEALTH IMPROVED, BUT NO FECES. (B)(6): PATIENT HEALTH DECLINE, TIGER2 REMOVED AFTER X-RAYS AND ABDOMINAL SCANNER, SURGERY (LAPAROTOMY, LAVAGE, DRAINAGE)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240668 TIGER 2 SELF-ADVANCING NASO JEJUNAL FEEDING TUBE KNT COOK, INC. NA 3862911

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention