BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOPAQUE, POLYURETHANE ENTERAL FEEDING TUBE WITH CONNECTOR

    MDR report key: 1709104 · Received May 4, 2010

    Report

    Report Number
    1709104
    Event Type
    Malfunction
    Date Received
    May 4, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 4, 2010
    Manufacturer
    NEOMED, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEOMED TUBING WAS USED TO RE-INTRODUCE BILE AND FECAL MATTER VIA THE STOMA INTO THE (B) (6). THE PT UNDERWENT A CLOSURE PROCEDURE FOR A JEJUNOSTOMY. FOUR FRAGMENTS OF A DISTAL ILEAL FEEDING TUBE WERE FOUND IN THE BOWEL ADJACENT TO THE STOMACH. THE PT HAD A PRENATAL DIAGNOSIS OF ILEAL ATRESIA. THE PT WAS ALSO DIAGNOSED WITH A COMPLICATED MECONIUM ILEUS AND JEJUNAL ATRESIA. STATUS POST A JEJUNAL RESECTION WITH DOUBLE BARREL JEJUNOSTOMY, A WASHOUT OF THE PERITONEAL CAVITY WAS DONE FOR MECONIUM PERITONITIS. BILE MAY HAVE AFFECTED THE TUBING INTEGRITY AND PERISTALSIS MAY HAVE FACILITATED THE TUBE FRAGMENTATION.

    Description of Event or Problem · 1

    NEOMED TUBING WAS USED TO RE-INTRODUCE BILE AND FECAL MATTER VIA THE STOMA INTO THE INFANT. THE PT UNDERWENT A CLOSURE PROCEDURE FOR A JEJUNOSTOMY. FOUR FRAGMENTS OF A DISTAL ILEAL FEEDING TUBE WERE FOUND IN THE BOWEL ADJACENT TO THE STOMACH. THE PT HAD A PRENATAL DIAGNOSIS OF ILEAL ATRESIA. THE PT WAS ALSO DIAGNOSED WITH A COMPLICATED MECONIUM ILEUS AND JEJUNAL ATRESIA. STATUS POST A JEJUNAL RESECTION WITH DOUBLE BARREL JEJUNOSTOMY, A WASHOUT OF THE PERITONEAL CAVITY WAS DONE FOR MECONIUM PERITONITIS. BILE MAY HAVE AFFECTED THE TUBING INTEGRITY AND PERISTALSIS MAY HAVE FACILITATED THE TUBE FRAGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOPAQUE, POLYURETHANE ENTERAL FEEDING TUBE WITH CONNECTOR TUBE, FEEDING,ENTERAL, 8.0 FRENCH ,40 CM KNT NEOMED, INC. * 08042009

    Patients

    Seq Age Sex Outcome Treatment
    1 5 WK NO OTHER THERAPIES