BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1500/2500CC ECO CANISTER LID

    MDR report key: 20084451 · Received August 28, 2024

    Report

    Report Number
    1057404-2024-00005
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 13, 2024
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "·A CUSTOMER OF DEROYAL REPORTED ITEM 71-0800 (800CC CANISTER ASSEMBLY), HAD A SHARP AREA THAT CUT AN EMPLOYEE'S FINGER." DEROYAL INDUSTRIES REQUESTED RETURN OF THE SAMPLE, AND NO SAMPLE WAS RETURNED FOR THIS QFI. IN THE PICTURE PROVIDED FOR THIS INVESTIGATION IT IS UNCLEAR IF THE PICTURED PATIENT PORT CAP HAS BEEN DAMAGED AS THE PHOTO IS BLURRY/PIXILATED. DEROYAL REVIEWED SPECIFICATIONS, FAILURE MODES AND EFFECTS ANALYSIS (FMEA), AND ANY CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS) RELEVANT AND NO ISSUE WERE FOUND. DEROYAL PERFORMED A SAMPLE INSPECTION OF 32 PARTS WITH NO NONCONFORMANCE IDENTIFIED. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). ROOT CAUSE: DUE TO NOT RECEIVING A RETURN SAMPLE, THE PHOTO PROVIDED BEING UNCLEAR, AND NOT RECEIVING THE ORIGINAL PACKAGING OR A PHOTO OF SAID PACKAGING TO CONFIRM IF THE BOX HAD BEEN DAMAGED DURING SHIPPING THE TRUE ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: NONE IDENTIFIED DUE TO THE TRUE ROOT CAUSE BEING UNDETERMINED. DEROYAL WILL CONTINUE TO MONITOR FOR ANY 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 REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    USER FACILITY REPORTED "WE HAD AN EMPLOYEE EVENT WHERE THEIR FINGER WAS CUT ON THE CANISTER WHEN GOING TO CHANGE IT OUT. THEY WENT TO USE THE CAP TO CLOSE THE CANISTER LID AND THE AREA WHERE IT WOULD ATTACH TO THE CANISTER WAS SHARP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127313 1500/2500CC ECO CANISTER LID BOTTLE, COLLECTION, VACUUM KDQ DEROYAL INDUSTRIES, INC. 30-1229TE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown