BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1083292 · Received July 28, 2008

    Report

    Report Number
    3006260740-2008-00053
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 15, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE PEG FEEDING TUBE DETACHING FROM THE LOCKING CLIP IS CONFIRMED. THE NOTES IN THIS FILE INDICATE, "THE CATHETER FELL INTO THE PATIENT'S STOMACH 9 DAYS AFTER PLACEMENT." THE GENIE TRICUSPID PLUG WAS RETURNED LOCKED TO ITS LOCKING RETENTION CLIP. THE PEG FEEDING TUBE WAS RETURNED LOOSE. THE PROXIMAL END OF THE PEG FEEDING TUBE WAS OBSERVED UNDER MAGNIFICATION AND EXHIBITS NO IMPRESSIONS IN THE TUBING THAT WOULD INDICATE ASSEMBLY. THE PROXIMAL END OF THE PONSKY FEEDING TUBE HAS CUT ON A NEAR RIGHT ANGLE. THE LOCKING RETENTION CLIP WAS OPENED AND THE GENIE INSERTION PLUG WAS THEN REMOVED. NEXT, THE GENIE PLUG WAS THEN INSERTED INTO THE PROXIMAL END OF THE PONSKY FEEDING TUBE. THE RETENTION CLIP WAS THEN SECURED TO THE FEEDING TUBE AND THE GENIE INSERT PLUG. AFTER THE DEVICE WAS ASSEMBLED, THE EXAMINER THEN STRETCHED THE FEEDING TUBE THAT IS ATTACHED TO THE RETENTION LOCKING CLIP EXCESSIVELY. THERE WAS NO MOVEMENT OR SEPARATION OF THE TUBING FROM THE RETENTION CLIP. THE DEVICE HAD BEEN IN PLACE FOR 3 DAYS PRIOR TO THE COMPLAINT INCIDENT. AT THIS TIME, THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A CHR OF LOT #HUSC0134 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE CATHETER FELL INTO THE PATIENT'S STOMACH 9 DAYS AFTER PLACEMENT. THE GENIE SYSTEM WAS PLACED IN THE PATIENT IN 2008. IT WAS CONFIRMED THAT THE PLUG WITH TRICUSPID VALVE WAS COMPLETELY INSTALLED. AT ABOUT 9 DAYS LATER, WHEN THE NURSE ATTEMPTED TO CONNECT THE CONNECTION TUBE TO THE CATHETER, HE/SHE FOUND THAT THE PLASTIC CLIP WITH SILICONE COVER AND THE PLUG WITH TRICUSPID VALVE WERE ON THE SURFACE OF THE PATIENT'S BODY, AND THAT THE CATHETER WAS NOT THERE. THE DOCTOR INSERTED AN ENDOSCOPE IMMEDIATELY, AND FOUND THAT THE CATHETER HAD FALLEN INTO THE PATIENT'S STOMACH. THE CATHETER WAS REMOVED ORALLY. AFTER THE REMOVAL OF THE CATHETER, THE PATIENT WAS TREATED CONSERVATIVELY WITH AN INSERTION OF ANOTHER DEVICE. THE PATIENT'S CONDITION WAS STABLE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C. R. BARD INC. (BASD) HUSC0134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention