BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT TUBE

    MDR report key: 2230729 · Received August 17, 2011

    Report

    Report Number
    1527460-2011-00059
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. PER LABEL INSTRUCTIONS, IT IS RECOMMENDED TO FILL THE BALLOON WITH 15-20ML WATER (PREFERRED) OR SALINE ON 18-26 FR G-TUBES. IF ADDITIONAL INFORMATION/CLARIFICATION IS OBTAINED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    REPORTER INDICATED PT EXPERIENCED INTERNAL BLEEDING SOME TIME AFTER PLACEMENT OF GASTROSTOMY TUBE. ON (B)(6) 2011, DR REPLACED PT'S G-TUBE WITH AN ABBOTT G-TUBE WITHOUT DIFFICULTY/RESISTANCE. BALLOON WAS INFLATED WITH 10CC OF STERILE WATER. THERE WERE NO COMPLICATIONS. ON (B)(6) 2011, CAREGIVER VISITED DISTRIBUTOR'S FACILITY TO PICK UP A COMPETITOR'S G-TUBE. PT WAS ON THEIR WAY TO HAVE THE G-TUBE PLACED AT THE DR'S OFFICE. CAREGIVER EXPLAINED THAT SOMETIME AFTER THE ABBOTT G-TUBE WAS PLACED THE PT EXPERIENCED INTERNAL BLEEDING. IT IS UNKNOWN THE DATE WHEN THE ABBOTT G-TUBE WAS REMOVED AND THE COMPETITOR'S TUBE WAS PLACED. IT WAS REPORTED THAT THERE WAS LEAKAGE OF INTERNAL GASTROSTOMY SITE WITH ASSOCIATED BLEEDING. ON (B)(6) 2011, PT WAS SEEN IN ER WITH A RECENT HISTORY OF MELENA. SHE WAS HEMODYNAMICALLY STABLE, PRESCRIBED PREVACID, AND ADVISED TO RETURN FOR OUTPATIENT FOLLOW-UP. ON (B)(6) 2011, PT HAD DR'S APPOINTMENT. THERE HAS BEEN NO FURTHER PASSAGE OF MELENIC APPEARING STOOL, AND NO NAUSEA/VOMITING, HEMATEMESIS, OR APPARENT ABDOMINAL PAIN/DISCOMFORT; ALTHOUGH, PT IS UNABLE TO COMMUNICATE EFFECTIVELY. ASSESSMENT IS A RECENT HISTORY OF MELENA, WHICH IS SUBSEQUENTLY RESOLVED. THERE IS NO EVIDENCE OF HEMODYNAMIC OR HEMATOLOGIC ABNORMALITIES AS THIS MAY HAVE BEEN RELATED TO SOME HEMODYNAMICALLY INSUFFICIENT BLEEDING AT THE GASTROSTOMY SITE. DR'S OFFICE HAS NOT SEEN PT SINCE (B)(6) 2011 AND HAS NOT REPLACED ANY OTHER G-TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT TUBE KNT, TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 54738 89496GZ

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other| R