BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSS GASTROSTOMY TUBE (5-17719)

    MDR report key: 5250056 · Received November 13, 2015

    Report

    Report Number
    1320599-2014-00001
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    July 15, 2013
    Report Date
    November 12, 2015
    Manufacturer
    MOSS TUBES, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    MALPRACTICE AGENT NOTIFIED OF IMPENDING LAW SUIT ((B)(6 )2014). (B)(4) SPOKE WITH (B)(6) (HOSPITAL ATTORNEY) WHO STATED THAT NO LAW SUIT SERVED ON ANY PARTY. THE HOSPITAL RESOLVED THE CASE 5 MONTHS AGO. NO ACTION WAS TAKEN AGAINST MOSS TUBES, INC. IN THE 29 YEARS MOSS TUBES, INC. EXISTENCE WE HAVE HAD ONLY ONE SIMILAR SITUATION. THE FINDINGS OF THIS CASE REVEALED THAT MOSS TUBES, INC. DID NOT HAVE ANY MANUFACTURING OR PRODUCT PROBLEMS. AT THE TIME OF THIS REPORTING WE CONTACTED OUR SUPPLIER AND HAD AN EXHAUSTIVE REVIEW OF THEIR COMPLAINT FILES DONE. THEY WERE UNABLE TO FIND ANY RECORDED INSTANCES OF PERFORMATED BOWEL WHEN A MOSS GASTROSTOMY FEEDING TUBE (5-17719). A SEARCH WAS, ALSO, DONE THROUGH MAUDE DATABASE WITH SIMILAR RESULTS.

    Description of Event or Problem · 1

    PT. (NP) WAS ADMITTED TO (B)(6) WITH A SMALL BOWEL OBSTRUCTION OBSERVED ON CT SCAN. THE PT. WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2013. DR. (B)(6) PERFORMED AN EXPLORATORY LAPAROTOMY, WITH A SMALL BOWEL RESECTION. DURING THAT SURGERY A MOSS GASTROSTOMY FEEDING TUBE WAS PLACED IN PT. THEREAFTER, THE PATIENT'S CONDITION DETERIORATED AND ON (B)(6) 2013 RADIOLOGY REPORTED THAT THE FEEDING TUBE HAD PERFORATED THROUGH THE THIRD PORTION OF THE PT.'S DUODENUM. THE PT. DEVELOPED AN OVERWHELMING SEPSIS AND THE DISCHARGE SUMMARY REPORTS THAT THE DEATH WAS DUE TO THE CONSEQUENCE OF SEPTIC SHOCK. A LAWSUIT WAS BEGUN AT (B)(6) 2013. AFTER MANY REQUESTS FOR THE TUBE IN QUESTION, PHONE CALLS TO HOSPITAL NO INFORMATION WAS GIVEN TO MOSS TUBES, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753510 MOSS GASTROSTOMY TUBE (5-17719) MOSS GASTROSTOMY TUBE (5-17719) KNT MOSS TUBES, INC. 5-17719 072611

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death