BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC GASTROSTOMY FEEDING TUBE

    MDR report key: 2123396 · Received November 14, 2008

    Report

    Report Number
    2123396
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 11, 2008
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) THERE WAS A PROCEDURE PERFORMED ON A PATIENT AT THE (B)(6) CALLED "OPEN PLACEMENT OF A GASTROSTOMY TUBE". IT WAS ONE A 2 DIFFERENT PROCEDURES THE OTHER BEING A TRACHEOSTOMY. AS THE SURGEON WAS CLOSING THE ABDOMINAL WOUND, THE G-TUBE SLIPPED OUT OF THE BELLY BECAUSE IT HAD A DEFECTIVE BALLOON WHICH POPPED SPONTANEOUSLY. (B)(4) LOT 325869 A MIC GASTROSTOMY TUBE. WE THEN GOT A SECOND TUBE (B)(4) LOT 398307 AND PLACED IT. THIS (B)(6) PATIENT SUBSEQUENTLY UNDERWENT A MAJOR SURGICAL HEAD AND NECK CANCER RESECTION THIS WEEK (B)(6) 2008. (B)(6) HIS G-TUBE FELL OUT THAT WAS PLACED ON (B)(6), THE CUFF HAVING DEFLATED SPONTANEOUSLY. AS A RESULT OF THESE DEFECTIVE TUBES, THIS MAN THEN HAD TO UNDERGO ANOTHER (3RD) PLACEMENT OF A TUBE IN THE OPERATING ROOM YESTERDAY (B)(6) 2008 -(B)(4) LOT # 399286 A MIC GASTROSTOMY FEEDING TUBE. NO FURTHER PROBLEMS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC GASTROSTOMY FEEDING TUBE FEEDING TUBE KNT KIMBERLY-CLARK REF- 0100-24 398307

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention