BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECANTER 50C

    MDR report key: 22852945 · Received August 20, 2025

    Report

    Report Number
    3005011024-2025-00010
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 14, 2025
    Manufacturer
    PREFERRED MEDICAL PRODUCTS, LLC
    Product Code
    KPE
    UDI-DI
    50749756281923
    PMA / PMN Number
    K811233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED WITH A MEDWATCH (B)(4), "TIP BROKE OFF INTO THE IV BAG." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT IT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, MEDLINE. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP INFORMATION WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED WITH A MEDWATCH (B)(4), "TIP BROKE OFF INTO THE IV BAG." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, AND IT WAS RECEIVED ON 9/3/2025. THE SAMPLE WAS REVIEWED BY QUALITY ASSURANCE AND CONFIRMED THAT THE TIP WAS BROKEN OFF. IT WAS ORIGINALLY STATED THAT A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, MEDLINE, BUT THE SUPPLIER WAS INCORRECTLY LISTED. THE CORRECT SUPPLIER IS PREFERRED MEDICAL PRODUCTS, LLC. THE SUPPLIER REVIEWED THE INCOMING INSPECTIONS AND ALL DEVICE HISTORY RECORDS FOR LOT NUMBERS N28156 INCLUDING RETURNED SAMPLES. ALL SPECIFICATIONS WERE MET. NO DESIGN OR SPECIFICATION CHANGE FROM PREFERRED MEDICAL PRODUCTS HAS BEEN MADE IN THE PAST 30 YEARS. ROOT CAUSE: NO SPECIFIC ROOT CAUSE WAS ABLE TO BE DETERMINED. POTENTIAL ROOT CAUSES: ONE POTENTIAL ROOT CAUSE IS A CHANGE TO THE SALINE BAG. THE BAG DECANTER IS DESIGNED TO BE USED IN CONJUNCTION WITH MULTIPLE SALINE BAG MANUFACTURERS; HOWEVER, THE DESIGN CANNOT ACCOUNT FOR THEIR CHANGES IN MATERIALS OR DESIGNS. ANOTHER POTENTIAL ROOT CAUSE COULD BE A USAGE ERROR IS WHICH TOO MUCH ANGLE OR PRESSURE COULD HAVE BEEN APPLIED TO THE TIP DURING APPLICATION. CORRECTIVE OR PREVENTIVE ACTION: BECAUSE NO SPECIFIC ROOT CAUSE COULD BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP INFORMATION IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED WITH A MEDWATCH (B)(4), "TIP BROKE OFF INTO THE IV BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155890 DECANTER 50C CONTAINER, I.V. KPE PREFERRED MEDICAL PRODUCTS, LLC 77-400274 62455174 50749756281923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown