BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRO-BLUETUBE

    MDR report key: 2466187 · Received July 26, 2011

    Report

    Report Number
    1066607-2011-00001
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 26, 2011
    Manufacturer
    SYNCRO MEDICAL INNOVATION, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN E-MAIL WAS RECEIVED FROM (B)(6) OF THE (B)(6) MEDICAL CENTER. IN A SUBSEQUENT PHONE CALL ON JUNE 26, MR. (B)(6) SHARED THE FOLLOWING INFORMATION: THE CARE GIVERS IN THE ICU PLACED A SYNCRO-BLUETUBE IN A (B)(6) MALE PATIENT ON JUNE 17. AFTER PLACEMENT A CONFIRMING X-RAY WAS TAKEN AND THE TUBE WAS SHOWN TO NOT BE IN THE CORRECT POSITION (NOT A DUODENAL PLACEMENT). A SECOND INSERTION WAS ATTEMPTED AND A SECOND X-RAY WAS TAKEN. THIS X-RAY CONFIRMED DUODENAL PLACEMENT OF THE TUBE. ENTERAL FEEDING WAS INITIATED AT A RATE OF 10 ML PER HOUR, AND WAS CONTINUED INTERMITTENTLY THROUGHOUT THE DAY. TWO DAYS LATER, THE PATIENT WAS COMPLAINING OF ABDOMINAL PAIN AND A GASTROGRAFFIN PROCEDURE WAS PERFORMED (DYE/CONTRAST WAS USED) TO OBTAIN VISUALIZATION OF THE ABDOMEN. THE GASTROGRAFFIN SHOWED THE TIP OF THE FEEDING TUBE TO BE EXTRA-LUMINAL. THE PATIENT WAS SENT TO THE OPERATING ROOM ON THE MORNING OF THE 20TH, THE PERFORATION WAS REPAIRED AND THE PATIENT IS DOING FINE. NO ADDITIONAL COMPLICATIONS WERE REPORTED. IN A SUBSEQUENT CONVERSATION, MR. (B)(6) REPORTED THAT IN THEIR OPINION, THE INCIDENT WAS NOT PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRO-BLUETUBE FEEDING TUBE FPD SYNCRO MEDICAL INNOVATION, INC. GFT 312 500183

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R