BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 19817503 · Received July 24, 2024

    Report

    Report Number
    1423537-2024-00063
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    May 2, 2023
    Report Date
    August 9, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KNT
    UDI-DI
    10884521661714
    PMA / PMN Number
    K180622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)NUMBER TO K180622. DEVICE MANUFACTURER DATE TO 14-DEC-2022. LABELED FOR SINGLE USE? TO YES. A PHOTO SAMPLE WAS RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL EVALUATION OF THE PHOTO SAMPLE, THE REPORTED WAS CONFIRMED; A RUPTURED BALLOON WAS CONFIRMED. THE ROOT CAUSE AND ACTION PLAN WILL BE DOCUMENTED THROUGH A FORMAL CORRECTIVE/PREVENTATIVE ACTION WHICH HAS BEEN INITIATED TO ADDRESS THE REPORTED CONDITION TO MITIGATE ANY FURTHER OCCURRENCES. CORRECTED: BRAND NAME FROM: GSTRO FEED TBE W/Y PRT 24FR TO: COVIDIEN. MANUFACTURER NAME TO FROM: CARDINAL HEALTH TO: CARDINAL HEALTH, INC. MODEL NUMBER/CATALOG NUMBER FROM: 8884720247 TO: 8884720205E. UNIQUE IDENTIFIER (UDI) # (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED SECTION G3 / G4 DATE RECEIVED BY MANUFACTURER FROM "10-JUN-2023" TO "10-JUN-2024".

    Additional Manufacturer Narrative · 0

    A PHOTO SAMPLE WAS PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL EVALUATION OF THE PHOTO SAMPLE, THE REPORTED ISSUE WAS CONFIRMED; A RUPTURED BALLOON CAN BE OBSERVED THE IMAGES. THE ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE BALLOON OF THE TUBE RUPTURED 4 WEEKS AFTER PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED, THE TUBE HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2303337 COVIDIEN TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884720205E 2234009664 10884521661714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female