BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORFLO NASOGASTRIC (NG) TUBE

    MDR report key: 1943035 · Received December 23, 2010

    Report

    Report Number
    1419949-2010-00013
    Event Type
    Other
    Date Received
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K831328A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT YET BEEN RETURNED FOR EVAL. RETENTION SAMPLES FROM THE SAME LOT WERE REVIEWED. TUBES WERE VISUALLY EXAMINED AS WELL AS PULL TESTED. ALL BOLUS ENDS WERE SECURELY ATTACHED TO THE FEEDING TUBE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE CHILD DISLODGED THE FEEDING TUBE AND WHEN THE RN CHECKED THE TUBE, SHE NOTICED 1/2 INCH OF THE BOTTOM PART OF THE TUBE WAS MISSING. THE TUBING END WAS BLUNT, NOT TORN APPEARING. THE MEASUREMENT FROM THE LAST MARKING OF THE TUBING TO THE END OF THE TUBING WAS 5.5 CM. AN X-RAY WAS DONE WHICH DID NOT REVEAL THE PIECE OF THE TUBE THAT WAS REPORTED MISSING. NO STOOL WAS EXAMINED FOR 48 HOURS ONCE DISCOVERED. THE TIP WAS NEVER FOUND. THE (B)(6) HAS HAD NO ILL EFFECTS OR SYMPTOMS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO NASOGASTRIC (NG) TUBE NG TUBE KNT CORPAK MEDSYSTEMS NA 42898

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other