BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRFLX 10FR 43IN W STY YPORT

    MDR report key: 16529630 · Received March 13, 2023

    Report

    Report Number
    9612030-2023-03636
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    February 27, 2023
    Report Date
    July 3, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNT
    UDI-DI
    10884521582996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. FIVE (5) PICTURES AND ONE DECONTAMINATED SAMPLE WAS PROVIDED FOR EVALUATION. THE SAMPLES WERE VISUALLY INSPECTED BASED ON PRODUCT SPECIFICATION. THE REPORTED CONDITION WAS CONFIRMED; DISASSEMBLY OF THE ENFIT BODY CONNECTOR WITH THE Y-PORT BODY CAUSING A LEAK BY THE DISASSEMBLY OF THE AND PORT. A WALK THROUGH OF THE MANUFACTURING PROCESS WAS CONDUCTED WHEREAS PROCESS AND CONTROLS WERE FOLLOWED; INCLUDING SUB-ASSEMBLIES, FINISHED PRODUCT ASSEMBLY, PACKAGING AND INSPECTIONS. IN ADDITION, QC INSPECTIONS INCLUDING A VISUAL INSPECTION OF PRODUCT SAMPLES TO VERIFY THE CORRECT ASSEMBLY OF THE DEVICE, AS WELL AS A 100% VISUAL INSPECTION DURING THE PROCESS, IN ORDER TO DETECT AND DISCARD ANY IDENTIFIED DEFECTS. THE POTENTIAL ROOT CAUSE FOR THE REPORTED CONDITION IS MISSING SOLVENT DURING ASSEMBLY BETWEEN THE "Y-PORT BODY ENTERAL" AND ENFIT BODY CONNECTOR. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR CUSTOMER COMPLAINT AND FEEDBACK NOTIFICATIONS FOR ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTS: WE HAD A KEOFEED THAT HAD THE SYRINGE LUMEN DISCONNECT FROM THE PURPLE Y-SITE. IT DIDN¿T APPEAR TO BREAK BECAUSE THE EDGES ARE CLEAN, IT JUST LET GO. IT WAS ONLY DISCOVERED WHEN TUBE FEED WAS ALL OVER THE BED. WE COULD PLACE IT BACK IN THE PORT BUT WITH THE PRESSURE OF A RUNNING TUBE FEED IT WOULD JUST ¿POP¿ OUT AGAIN. AN INVESTIGATION REPORT (IR) WAS FILLED OUT AND THE NURSE IS AT THE BEGINNING STAGES OF FOLLOW UP. ADDITIONAL INFORMATION RECEIVED ON 03/13/23 STATED THAT THE DEVICE WAS REMOVED AND REPLACED WITH A NEW FEEDING TUBE PLACED AND XRAY'S TAKEN FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576568 ENTRFLX 10FR 43IN W STY YPORT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH 8884721088E 223541264 10884521582996

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown