BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFELINER SUCTION CANISTER, 1500CC

    MDR report key: 21880691 · Received April 22, 2025

    Report

    Report Number
    1057404-2025-00013
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    March 26, 2025
    Report Date
    July 10, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDQ
    UDI-DI
    50749756377053
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "WE ARE HAVING DIFFICULTY WITH CANISTER LINER CONTENTS GETTING INTO THE PLASTIC SECTION OF THE SUCTION HEAD. NURSING LEADERSHIP EXPERIMENTED WITH WATER AND DETERMINED THAT THE VALUE TO KEEP FLUID FROM LEAKING OUT OF THE LINER INTO THE CANISTER AND SUCTION HEAD IS NOT WORKING THUS LEADING TO URINE AND OTHER FLUIDS CONTAMINATING THE SUCTION HEAD AND NEEDING TO BE SENT TO STERILE PROCESSING FOR CLEANING." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "WE ARE HAVING DIFFICULTY WITH CANISTER LINER CONTENTS GETTING INTO THE PLASTIC SECTION OF THE SUCTION HEAD. NURSING LEADERSHIP EXPERIMENTED WITH WATER AND DETERMINED THAT THE VALUE TO KEEP FLUID FROM LEAKING OUT OF THE LINER INTO THE CANISTER AND SUCTION HEAD IS NOT WORKING THUS LEADING TO URINE AND OTHER FLUIDS CONTAMINATING THE SUCTION HEAD AND NEEDING TO BE SENT TO STERILE PROCESSING FOR CLEANING." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE FOR RETURN. DEROYAL REVIEWED THE WORK ORDER FOR THE LOT REPORTED. AN INVENTORY CHECK WAS PERFORMED ON A DIFFERENT LOT AS NO PRODUCT WAS AVAILABLE FROM THE LOT FROM THE REPORTED COMPLAINT. ALL 32 CANISTERS INSPECTED WERE FOUND TO BE ACCEPTABLE AND WITHIN SPECIFICATION. A REVIEW OF THE RISK ANALYSIS WAS CONDUCTED AND NO UPDATES WERE REQUIRED. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE THE SAMPLE WAS NOT AVAILABLE FOR RETURN, THE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. POTENTIAL ROOT CAUSE: WHILE IT COULD NOT BE CONFIRMED, THERE IS A POTENTIAL THAT THIS ISSUE COULD BE CAUSED BY AN INADEQUATE GLUE BEAD OR OVERLAPPING OF GLUE BEAD. THIS COULD CAUSE HIGH OR LOW SPOTS THAT COULD ALLOW FOR A LEAK PATH. CORRECTIVE AND PREVENTIVE ACTIONS: WHILE THE ROOT CAUSE WAS NOT ABLE TO BE SPECIFICALLY CONFIRMED, A RETRAINING OF EMPLOYEES ON VISUAL ACCEPTANCE OF THE GLUE BEAD WAS CONDUCTED. THE LID EVALUATION FORM WAS ALSO UPDATED TO INCLUDE THAT THE VISUAL CHECK BE CONDUCTED AND RECORDED FOR GLUE BEAD ADEQUACY. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "WE ARE HAVING DIFFICULTY WITH CANISTER LINER CONTENTS GETTING INTO THE PLASTIC SECTION OF THE SUCTION HEAD. NURSING LEADERSHIP EXPERIMENTED WITH WATER AND DETERMINED THAT THE VALUE TO KEEP FLUID FROM LEAKING OUT OF THE LINER INTO THE CANISTER AND SUCTION HEAD IS NOT WORKING THUS LEADING TO URINE AND OTHER FLUIDS CONTAMINATING THE SUCTION HEAD AND NEEDING TO BE SENT TO STERILE PROCESSING FOR CLEANING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353503 SAFELINER SUCTION CANISTER, 1500CC BOTTLE, COLLECTION, VACUUM KDQ DEROYAL INDUSTRIES, INC. PHESL-1500B 61975549 50749756377053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown