BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24F

    MDR report key: 6726132 · Received July 19, 2017

    Report

    Report Number
    3006260740-2017-01098
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741037177
    PMA / PMN Number
    K063118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY 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 TRI-FUNNEL BALLOON BURSTS DUE TO INFLATION WAS CONFIRMED, AND THE CAUSE APPEARS TO BE USE-RELATED. THE DEVICE RETURNED WAS A 24 FR, 20 CC INFLATION VOLUME TRI-FUNNEL REPLACEMENT GASTROSTOMY DEVICE. VISUAL OBSERVATION FOUND ONE SPLIT IN THE BALLOON, EXTENDING LONGITUDINALLY, ABOUT 1.4 CM AND 1.3 CM IN LENGTH, RESPECTIVELY. THE SIDES OF THE SPLIT WERE NOTICEABLY DEFORMED AND STRETCHED. WHITISH MATERIAL WAS FOUND INSIDE THE MAIN LUMEN. BROWNISH RESIDUE WAS FOUND AT THE INFLATION HOLE AND WITHIN THE BROKEN BALLOON. THE SPLIT IN THE BALLOON WAS DIRECTLY OVER THE INFLATION HOLE. MICROSCOPIC EVALUATION FOUND THAT THE SIDES OF EACH SPLIT WERE FOUND TO APPEAR TO FIT TOGETHER WELL. THE SURFACES OF EACH BREAK DID NOT APPEAR TO BE STRIATED OR SHINY, BUT GRANULAR. SOME EVIDENCE OF TEARING WAS PRESENT IN EACH CASE, BOTH SPLITS HAVING A ¿TOOTH¿ OF MATERIAL EXTENDING FROM THE MAIN FRACTURE. THE TYPE OF FRACTURE SURFACE, AS WELL AS THE STRETCHING AROUND THE SPLIT, IS CONSISTENT WITH BURST FRACTURE DUE TO OVERPRESSURIZATION. THE IFU STATES THE FOLLOWING; ¿NEVER USE AIR TO FILL BALLOON AS THIS CAN RESULT IN INCORRECT BALLOON INFLATION SIZE AND DEVICE RETENTION AND COULD POTENTIALLY LEAD TO INADVERTENT DEVICE REMOVAL BY THE PATIENT. DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AS THIS MAY CAUSE EXCESSIVE PRESSURE ON THE GASTRIC MUCOSA AND MIGRATION OF THE INTERNAL BALLOON INTO THE PERITONEAL CAVITY WHICH CAN RESULT IN SERIOUS CONSEQUENCES INCLUDING PERITONITIS, SEPSIS AND POTENTIALLY DEATH. DO NOT ADMINISTER FEEDING OR MEDICATION INTO THE COLOR-CODED BALLOON INFLATION LUMEN AS THIS LUMEN DOES NOT PROVIDE ACCESS FOR NUTRITIONAL SUPPORT TO THE PATIENT¿S GI TRACT AND COULD POTENTIALLY DAMAGE THE BALLOON AND CAUSE BLOCKAGE OF THE BALLOON INFLATION LUMEN. IF PLACEMENT AND PATENCY CANNOT BE CONFIRMED DO NOT BEGIN FEEDING. PLACEMENT OR SLIPPAGE OF THE DEVICE INTO THE PERITONEAL CAVITY WILL RESULT IN SERIOUS CONSEQUENCES INCLUDING PERITONITIS, SEPSIS AND POTENTIALLY DEATH.¿ ¿3. CHECK BALLOON VOLUME EVERY 7 TO 10 DAYS FOR CORRECT INFLATION VOLUME USING THE FOLLOWING STEPS: DISCONTINUE FEEDING. USE A LUER-TIP SYRINGE TO COMPLETELY EVACUATE WATER FROM BALLOON. DISCARD EVACUATED WATER. REINFLATE BALLOON WITH APPROPRIATE AMOUNT OF WATER. MAXIMUM INFLATION VOLUME IS PRINTED ON THE COLOR-CODED BALLOON INFLATION PORT. 4. FOR OPTIMAL PERFORMANCE, THE BARD* TRI-FUNNEL TUBE SHOULD BE REPLACED EVERY 30 DAYS OR AS REQUIRED TO ENSURE BALLOON PATENCY AND AN UNOCCLUDED TUBE LUMEN.¿

    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 NGAV1537 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (NGAV1537) HAVE BEEN REPORTED FROM THE SAME (B)(6) FACILITY. DEVICE NOT YET RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS RUPTURED BY INFLATION. NO OTHER INFORMATION WAS REPORTED. THIS REPORT ADDRESSES RUPTURE TWO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS RUPTURED BY INFLATION. NO OTHER INFORMATION WAS REPORTED. THIS REPORT ADDRESSES RUPTURE TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504612 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24F REPLACEMENT G-TUBES KNT BARD ACCESS SYSTEMS N/A NGAV1537 00801741037177

    Patients

    Seq Age Sex Outcome Treatment
    1