BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO GASTROSTOMY TUBE

    MDR report key: 330230 · Received May 1, 2001

    Report

    Report Number
    1528738-2001-00023
    Event Type
    Injury
    Date Received
    May 1, 2001
    Date of Event
    March 28, 2001
    Report Date
    April 2, 2001
    Manufacturer
    ROSS PRODUCTS DIV/ABBOTT LABORATORIES
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS INSERTED IN 2000. THE BALLOON RUPTURED ON EVENT DATE, AND THE TUBE CAME OUT. A NEW DEVICE WAS INSERTED 15 MINUTES LATER. PLACEMENT CHECKED PER AUSCULTATION AND RESIDUAL CHECK. FREQUENTLY PT HAS NO RESIDUAL WHEN CHECKED. PT DID NOT PRESENT WITH ANY UNUSUAL SIGNS OR SYMPTOMS DURING OR AFTER INSERTION OF TUBE. PT THEN RECEIVED MEDICATION AND A 600 CC BOLUS FEEDING. AT THE END OF THE FEEDING, PT BECAME EXTREMELY DIAPHORETIC ARREARING SHOCKY. BP 190/100. PULSE 60 - 70 REGULAR, O2 SAT >90%. FACIAL GRIMACING SHOWING PAIN. PT MONITORED, PHYSICIAN NOTIFIED, PT TRANSPORTED TO E.R. FOR EVAL. EMERGENCY SURGERY FOR GASTRIC PERFORATION AND ABDOMINAL CAVITY LAVAGE. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20075 FLEXIFLO GASTROSTOMY TUBE 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIV/ABBOTT LABORATORIES 50114 58-351-GE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R