BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JEJUNAL FEEDING TUBE 9F

    MDR report key: 8796449 · Received July 16, 2019

    Report

    Report Number
    3006260740-2019-01971
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    KNT
    UDI-DI
    00801741051630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS 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 ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000319. JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES ALLEGEDLY EXPERIENCED MATERIAL FRAYED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6); HOWEVER, WEIGHT AND GENDER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588471 JEJUNAL FEEDING TUBE 9F JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES KNT BARD ACCESS SYSTEMS 000319 ASCZF007 00801741051630

    Patients

    Seq Age Sex Outcome Treatment
    1