BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1211042 · Received October 24, 2008

    Report

    Report Number
    3006260740-2008-00171
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 30, 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 COMPLAINANT INDICATES THE DEVICE HAS BEEN IN PLACE FOR 93 DAYS PRIOR TO THE COMPLAINT INCIDENT." THE GENIE TRICUSPID PLUG WAS RETURNED LOCKED TO ITS LOCKING RETENTION CLIP. THE PONSKY FEEDING TUBE WAS RETURNED LOOSE. THE PROXIMAL END OF THE PONSKY FEEDING TUBE HAS BEEN 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. 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 IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE PATIENT FELL OFF OF THE BED CAUSING THE PLUG TO DETACH AND THE CATHETER TO FALL INTO HIS/HER STOMACH. THE INDWELLING PERIOD WAS 93 DAYS. THE CATHETER WAS REMOVED ENDOSCOPICALLY AND THE STOMA SITE WAS CLOSED WITH CLIPPING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention