BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24F

    MDR report key: 7360128 · Received March 21, 2018

    Report

    Report Number
    3006260740-2018-00490
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    January 8, 2018
    Report Date
    June 7, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741037177
    PMA / PMN Number
    K063118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER

    Narratives

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF NGAU3559 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF MISLABELING ON TRI-FUNNEL PACKAGING IS CONFIRMED, AND THE CAUSE IS DETERMINED TO BE MANUFACTURING RELATED. THE SAMPLE RETURNED CONSISTED OF TWO PHOTOGRAPHS SHOWING A BOX AND A POUCH FOR TRI-FUNNEL PRODUCT. VISUAL OBSERVATION FOUND THAT THE PHOTOGRAPHS WERE LABELED FOR A BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE. THE LOT NUMBER ON BOTH THE POUCH AND CASE LABELS, AS WELL AS THE BOX LABEL PRODUCT NUMBER IDENTIFY THE PRODUCT AS 000724, A 24-FR TRIFUNNEL GASTROSTOMY TUBE. IN ADDITION, THE BLUE INFLATION CAP VISIBLE THROUGH THE CLEAR PLASTIC OF THE POUCH DENOTES A 24 FR PRODUCT. HOWEVER, THE POUCH LABEL IDENTIFIES THE PRODUCT AS 000718, AN 18 FR TRIFUNNEL. BAW0738881, THE DRAWING CORRESPONDING TO PK0738881, THE SINGLE-UNIT LABEL FOUND IN THE BILL OF MATERIALS FOR PRODUCT 000724 AT THE TIME OF COMPLETION OF THIS LOT, DEPICTS 000724 AS THE PRODUCT NUMBER. THE LABEL NUMBER OF THIS POUCH LABEL IS NOT VISIBLE IN THE PHOTOGRAPHS AND THEREFORE CANNOT BE COMPARED TO THE BILL OF MATERIALS LISTED IN JDE FOR 000724. THE COMPLAINT IS CONFIRMED AND FOUND TO BE RELATED TO THE LABELING STAGE OF THE MANUFACTURING PROCESS. A LOT HISTORY REVIEW (LHR) OF NGAU3559 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 18 FR GASTRONOMY TUBE WAS INSIDE OF A BOX LABELED AS CONTAINING 24 FR GASTRONOMY TUBES. THIS ISSUE WAS DISCOVERED BY A CUSTOMER WHO BOUGHT ONE FROM THE DISTRIBUTOR, NOTICED THE LABELING DISCREPANCY, AND RETURNED THE PRODUCT THE SAME DAY IN THE UNOPENED PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT. THE SALES REP ALLEGES THAT THE BOX SHOULD HAVE CONTAINED 100: 24 FR G-TUBES, AND OF THOSE 100, 3 MORE OF THEM WERE LABELED AS 18 FR. G-TUBES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 18 FR GASTRONOMY TUBE WAS INSIDE OF A BOX LABELED AS CONTAINING 24 FR GASTRONOMY TUBES. THIS ISSUE WAS DISCOVERED BY A CUSTOMER WHO BOUGHT ONE FROM THE DISTRIBUTOR, NOTICED THE LABELING DISCREPANCY, AND RETURNED THE PRODUCT THE SAME DAY IN THE UNOPENED PACKAGE. THE DEVICE WAS NOT USED ON A PATIENT. THE SALES REP ALLEGES THAT THE BOX SHOULD HAVE CONTAINED 100: 24 FR G-TUBES, AND OF THOSE 100, 3 MORE OF THEM WERE LABELED AS 18 FR. G-TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201860 BARD TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE 24F TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BARD ACCESS SYSTEMS 000724 NGAU3559 00801741037177

    Patients

    Seq Age Sex Outcome Treatment
    1