BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-FUNNEL REPL GAST 20F

    MDR report key: 9174939 · Received October 10, 2019

    Report

    Report Number
    3006260740-2019-02977
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    July 30, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741037153
    PMA / PMN Number
    K063118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ORIGINALLY DETERMINED TO BE A MALFUNCTION REPORTABLE EVENT ON (B)(6) 2019 AND REPORTED TO THE FDA THROUGH THE QUARTERLY VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM. BDPI RECEIVED A NOTIFICATION FROM THE FDA ON 9/16/2019 STATING THAT THE PROCODE KNT IS INELIGIBLE FOR THE VMSR PROGRAM; THEREFORE, THE MDR DATE OF AWARENESS WAS MODIFIED TO REFLECT THE DATE OF THE FDA NOTIFICATION OF PROCODE INELIGIBILITY. MANUFACTURING REVIEW: NEITHER A LOT HISTORY REVIEW NOR A DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. INVESTIGATION SUMMARY: ONE TRI-FUNNEL 20F CAT#000720 WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE BALLOON APPEARED TO INFLATE ASYMMETRICALLY. HOWEVER, AFTER FURTHER EVALUATION FROM THE MANUFACTURING SITE, THE ASYMMETRY WAS FOUND TO BE WITHIN THE ACCEPTABLE SPECS FOR THIS PRODUCT. THE INVESTIGATION IS UNCONFIRMED FOR THE ALLEGED ASYMMETRY DUE TO THE DEVICE BEING WITHIN THE ALLOWABLE LIMITS FOR THIS DEVICE. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION, THE FEEDING DEVICE BALLOON ALLEGEDLY INFLATED ASYMMETRICALLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS ORIGINALLY DETERMINED TO BE A MALFUNCTION REPORTABLE EVENT ON (B)(6)2019 AND REPORTED TO THE FDA THROUGH THE QUARTERLY VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM. BDPI RECEIVED A NOTIFICATION FROM THE FDA ON 9/16/2019 STATING THAT THE PROCODE KNT IS INELIGIBLE FOR THE VMSR PROGRAM; THEREFORE, THE MDR DATE OF AWARENESS WAS MODIFIED TO REFLECT THE DATE OF THE FDA NOTIFICATION OF PROCODE INELIGIBILITY. THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION, THE FEEDING DEVICE BALLOON ALLEGEDLY INFLATED ASYMMETRICALLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970328 TRI-FUNNEL REPL GAST 20F FEEDING KNT BARD ACCESS SYSTEMS 000720 UNKNOWN 00801741037153

    Patients

    Seq Age Sex Outcome Treatment
    1