BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMEDIARY TUBESET 24PK

    MDR report key: 14547549 · Received May 31, 2022

    Report

    Report Number
    1221934-2022-01523
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    February 9, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705015764
    PMA / PMN Number
    K954465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. THE PACKAGE WAS UNOPENED. IT WAS OBSERVED THAT THE ¿FEMALE VENTED CAP BLUE¿ WAS DETACHED FROM THE TIP. THE EXTERNAL PACKAGING DID NOT PRESENT ANY ANOMALIES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER: 3001981 , AND NO NON-CONFORMANCES WERE IDENTIFIED. BASED ON THE CONDITION OF THE DEVICE RECEIVED, THIS COMPLAINT CAN BE CONFIRMED. A MANUFACTURING INVESTIGATION WILL BE PERFORMED; THE PROCESS WAS REVIEWED, AND IT WAS FOUND THAT THE WORK INSTRUCTIONS FOR PART NUMBERS 284610, 281103, WHERE THE BLUE VENTED CAP (P3101312) IS USED, DOES NOT INSTRUCT THE OPERATOR TO SCREW IN THE CAP TO THE BLUE MALE LUER-LOCK P3101369. ALTHOUGH INSTRUCTIONS ARE VAGUE, IT IS GENERALLY UNDERSTOOD BY OPERATORS THAT THE CAP MUST BE SCREWED ONTO THE LUER, AND THEREFORE ONLY ONE LOOSE CAP WAS DISCOVERED FOR LOT 3001981. THE CORRECTIVE ACTIONS ARE A QUALITY ALERT WAS POSTED ON THE PRODUCTION FLOOR AND TRAINING WAS PERFORMED WITH OPERATORS. PPCR 22-0279 WAS GENERATED TO UPDATE WORK INSTRUCTIONS FOR PART NUMBERS 284610 AND 281103 TO INSTRUCT OPERATORS TO SCREW THE BLUE CAP (P3101312) ONTO THE BLUE MALE LUER LOCK (P3101369). AS AGREED, A NONCONFORMANCE RECORD WAS CREATED TO DOCUMENT THE ROOT CAUSE AND IDENTIFY A CORRECTIVE AND/OR PREVENTIVE ACTION PLAN. THE MANUFACTURER WILL CONTINUE TO MANUFACTURE THE PRODUCT UNDER THE RIGOROUS REQUIREMENTS OF OUR CERTIFIED QUALITY MANAGEMENT SYSTEM. AT THIS POINT IN TIME, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT THE BLUE CAP OF THE FMS FLUID MANAGEMENT SYSTEM INTERMEDIARY TUBING WITHOUT ONE-WAY VALVE WAS OFF. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ¿FEMALE VENTED CAP BLUE¿ WAS DETACHED FROM THE TIP ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724882 INTERMEDIARY TUBESET 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE HRX DEPUY MITEK LLC US 281103 3001981 10886705015764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown