BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO

    MDR report key: 19519550 · Received June 12, 2024

    Report

    Report Number
    9612030-2024-00085
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 15, 2024
    Report Date
    August 28, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNT
    UDI-DI
    10884521582972
    PMA / PMN Number
    K833621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE CORRECTED OR COMPLETED: BRAND NAME: KANGAROO. MANUFACTURER NAME: CARDINAL HEALTH 200, INC. UNIQUE IDENTIFIER (UDI) #:(B)(4). PMA/510(K)NUMBER: K833621 LABELED FOR SINGLE USE: YES. INVESTIGATION SUMMARY: DECONTAMINATED SAMPLES WERE RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOTS WERE REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL AND FUNCTIONAL EVALUATION OF THE SAMPLES, THE REPORTED ISSUE WAS CONFIRMED; A RUPTURED TUBE WAS FOUND IN 1 OF THE SAMPLES. A ROOT CAUSE ANALYSIS INDICATED THAT THIS OCCURRED DURING OUR MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DECONTAMINATED SAMPLES WERE RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOTS WERE REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL AND FUNCTIONAL EVALUATION OF THE SAMPLES, THE REPORTED ISSUE WAS CONFIRMED; A RUPTURED TUBE WAS FOUND IN 1 OF THE SAMPLES. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. CORRECTED INVESTIGATION SUMMARY. FROM: DECONTAMINATED SAMPLES WERE RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOTS WERE REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL AND FUNCTIONAL EVALUATION OF THE SAMPLES, THE REPORTED ISSUE WAS CONFIRMED; A RUPTURED TUBE WAS FOUND IN 1 OF THE SAMPLES. A ROOT CAUSE ANALYSIS INDICATED THAT THIS OCCURRED DURING OUR MANUFACTURING PROCESS. TO: DECONTAMINATED SAMPLES WERE RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD FOR THE POSSIBLE LOTS WERE REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL AND FUNCTIONAL EVALUATION OF THE SAMPLES, THE REPORTED ISSUE WAS CONFIRMED; A RUPTURED TUBE WAS FOUND IN 1 OF THE SAMPLES. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. CORRECTED H6 EVALUATION CODES: FROM: 125, TO: 180. FROM: 25, TO: 4315.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN THEY REMOVED THE TUBE AFTER THE PARENT REPORTED A BLOCKAGE, IT WAS NOTED THAT THE ENTIRE WEIGHTED AREA OF THE NASOGASTRIC TUBE WAS MISSING. THE TUBE HAD BEEN IN SITU FOR 3 WEEKS. THE 2.5 YEARS OLD PATIENT REQUIRED ADMISSION AND MULTIPLE X-RAYS TO TRY TO FIND MISSING COMPONENT. THERE WAS A HIGH DEGREE OF ANXIETY FOR THE PARENTS AND CHILD. PER ADDITIONAL INFORMATION RECEIVED, THE WEIGHTED TIP WAS NOT LOCATED IN THE PATIENT'S BODY. IT IS BELIEVED TO HAVE BEEN PASSED BY THE INFANT BUT WAS NOT NOTICED BY THE PARENTS. AS PREVIOUSLY REPORTED, SCANS WERE PERFORMED TO LOCATE THE MISSING WEIGHTED TIP BUT PRODUCED A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372307 KANGAROO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 8884720858E 10884521582972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown