BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 20F

    MDR report key: 7154724 · Received December 29, 2017

    Report

    Report Number
    3006260740-2017-02333
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Report Date
    June 7, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741037153
    PMA / PMN Number
    K063118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A BROKEN TRI-FUNNEL BALLOON IS CONFIRMED AND THE CAUSE CANNOT BE DETERMINED. THE DEVICE RETURNED WAS ONE 20 FR TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE (000720) AND ONE LABEL IDENTIFYING THE PRODUCT AS 000720, FROM LOT NGAY4815. VISUAL OBSERVATION FOUND WHITISH RESIDUES WITHIN THE MAIN LUMEN AND WHAT APPEARED TO BE A LONGITUDINAL HOLE IN THE SIDE OF THE BALLOON. THE DEVICE LEAKED FROM THIS HOLE DURING INFUSION. MICROSCOPIC EVALUATION FOUND THE BALLOON BREAK TO BE LONGITUDINAL AND VERY STRAIGHT, WITH A FINELY GRANULAR BREAK SURFACE, WITH A PROTRUSION ON ONE SIDE NEAR THE MIDDLE THAT HAD AN IRREGULAR BREAK PATTERN. THE AREA AROUND THE BREAK FELT SMOOTH. THE LONGITUDINAL SLIT APPEARS TO BE THE RESULT OF A BURST, BUT THE IRREGULAR DAMAGE AT THE PROTRUSION OF MATERIAL AT THE BURST SITE APPEARS TO BE THE POINT OF ORIGINATION, SUGGESTING THAT IT WAS PRESENT BEFORE THE BURST OCCURRED. THE SOURCE OF THIS DAMAGE IS UNKNOWN, AND THEREFORE THE CAUSE OF THE EVENT IS UNKNOWN. POSSIBLE CONTRIBUTING FACTORS INCLUDE NEEDLE PRICKING, TOOL DAMAGE, AND OVERPRESSURIZATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF NGAY4815 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. DEVICE NOT RETURNED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF THE TRI-FUNNEL PROBE BROKE AND THE PROBE CAME OUT TWO DAYS AFTER INSERTION. NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF THE TRI-FUNNEL PROBE BROKE AND THE PROBE CAME OUT TWO DAYS AFTER INSERTION. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935183 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 20F TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BARD ACCESS SYSTEMS 000720 NGAY4815 00801741037153

    Patients

    Seq Age Sex Outcome Treatment
    1