BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFELINER SUCTION CANISTER, 1500CC

    MDR report key: 21880692 · Received April 22, 2025

    Report

    Report Number
    1057404-2025-00014
    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 34 CANISTERS FROM THE REPORTED LOT RETAINED AT THE DISTRIBUTION FACILITY. CANISTERS WERE FOUND TO HAVE GLUE BEAD ISSUES IN BOTH VISUAL INSPECTION AND IN TESTING. 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: THE ROOT WAS DETERMINED TO BE 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: 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
    1353504 SAFELINER SUCTION CANISTER, 1500CC BOTTLE, COLLECTION, VACUUM KDQ DEROYAL INDUSTRIES, INC. PHESL-1500B 61932792 50749756377053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown