BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WESTMED LLC

    MDR report key: 17279596 · Received July 7, 2023

    Report

    Report Number
    2028807-2023-00019
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 7, 2023
    Manufacturer
    WESTMED LLC
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WOULD DELAY THERAPY AND INTERFERE WITH OXYGEN DELIVERY. COMPLAINT HISTORY REVIEWED. THERE ARE NO SIMILAR COMPLAINTS FOR 16-0503 IN THE PREVIOUS 24 MONTHS. NO SIMILAR COMPLAINTS IN PREVIOUS 24 MONTHS FOR PRODUCT GROUP 84- O2 CANNULA WESTMED UNDER "OBSTRUCTION/OCCLUSION" DHR REVIEWED. A TOTAL OF 78 2-2 ADAPTORS WERE SCRAPPED FOR DEFECT CODE "06-001" FAILED LEAKAGE TEST. NO SCRAP RECORD FOR DEFECT CODE "06-006" FAILED OBSTRUCTION TEST. LOT PASSED ALL INSPECTIONS. TM-110 AND OI-009 REVIEWED. STEP 4.2.4: "DIP THE SMALL OPENING SIDE OF THE ADAPTOR PN 20107 THROUGH THE RECTANGULAR INLET OF THE SOLVENT DISPENSER UNTIL TOUCHING THE BOTTOM OF THE DISPENSER, REMOVE SOLVENT EXCESS FROM INSIDE OF THE ADAPTOR BY USING A PAPER TOWEL, THEN ASSEMBLE IMMEDIATELY BOTH BIFLO TUBES INTO THE SMALL OPENING SIDE OF THE 2-2 ADAPTOR UNTIL THE STOP." MOST LIKELY ROOT CAUSE OF DEFECT IS TOO MUCH SOLVENT WAS APPLIED, OR TUBING WAS INSERTED PAST THE STOP. SAMPLING PLANS ARE IN PLACE TO CATCH DEFECTS. RISK(PFMEAN-20001F): STEP 100: PRODUCTION VERIFIES AND FOLLOWS ASSEMBLY INSTRUCTIONS - BAD ASSEMBLY - TEST FAILURE - S=7 O=1 D=5. RPN=35.

    Additional Manufacturer Narrative · 0

    THIS WOULD DELAY THERAPY AND INTERFERE WITH OXYGEN DELIVERY.

    Description of Event or Problem · 0

    THE TUBE WAS CLOSED WHERE OXYGEN SHOULD FLOW.

    Description of Event or Problem · 0

    THE TUBE WAS CLOSED WHERE OXYGEN SHOULD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056290 WESTMED LLC ADULT NASAL CANNULA 7' CO2/O2 SL W/MALE LUER MCKESSON CAT WESTMED LLC 16-0503 394698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other