BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-FUNNEL REPL GAST 20F

    MDR report key: 8528614 · Received April 18, 2019

    Report

    Report Number
    3006260740-2019-00976
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Report Date
    July 25, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741037153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OF THE 2 DEVICES, BOTH LOT NUMBERS WERE PROVIDED, AND LOT HISTORY REVIEWS WERE PERFORMED. THE TWO SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. THE DEVICES WERE LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 000720 REPLACEMENT GASTROSTOMY TUBE ALLEGEDLY RUPTURED. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE TWO EVENTS, INVOLVED PATIENTS WITH NO REPORTED PATIENTS INJURY. OF THE TWO EVENTS, BOTH PATIENTS WERE 86 YEARS OF AGE, 57 KGS AND MALE.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE TWO DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE TWO SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES TWO MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 000720 REPLACEMENT GASTROSTOMY TUBE ALLEGEDLY RUPTURED. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE TWO EVENTS, INVOLVED PATIENTS WITH NO REPORTED PATIENTS INJURY. OF THE TWO EVENTS, BOTH PATIENTS WERE (B)(6) YEARS OF AGE, (B)(6) KGS AND MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322355 TRI-FUNNEL REPL GAST 20F REPLACEMENT GASTROSTOMY TUBE KNT BARD ACCESS SYSTEMS 000720 NGBX2200, NGBS1443 00801741037153

    Patients

    Seq Age Sex Outcome Treatment
    1