BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12FX20CM STRAIGHT TPL LMN

    MDR report key: 17748410 · Received September 14, 2023

    Report

    Report Number
    2518902-2023-00062
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 21, 2023
    Report Date
    November 16, 2023
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    MPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE TRIPLE LUMEN CATHETER WAS RETURNED FOR EVALUATION WITH THE SUTURE WING SEPARATED FROM THE CATHETER HUB. SUTURES WERE ATTACHED TO THE SUTURE WING. THE HUB AND INNER DIAMETER OF THE SUTURE WING SHOWED NO OBVIOUS DEFECTS. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE CONTRACT MANUFACTURER. DIMENSIONAL MEASUREMENTS WERE TAKEN OF THE RETURNED SAMPLE. THE NOTCH DEPTH OF THE HUB AND THE SUTURE WING INNER ID ARE IN SPECIFICATION. THESE DIMENSIONS ARE WHAT PREVENT THE SUTURE WING FROM SEPARATING FROM THE HUB. THE OPERATION TO ATTACH THE SUTURE WING TO THE HUB IS PERFORMED BY HAND. A SMALL DROP OF SILICONE FLUID IS APPLIED, AND THE SUTURE WING IS PLACED BY PUSHING THE WING ONTO THE HUB UNTIL IT IS PROPERLY SEATED IN THE CORRECT POSITION ON THE HUB. THE OPERATOR ROTATES THE WING A FEW TIMES TO ENSURE THAT IT TURNS FREELY ON THE HUB. THE OPERATOR WIPES ALL EXCESS SILICONE FROM THE HUB. AN AQL INSPECTION IS PERFORMED TO VERIFY THE WING IS APPLIED TO THE HUB SECURELY, SEATED PROPERLY IN THE GROOVE AND ROTATES FREELY. DURING INSPECTION NO PROBLEMS WERE FOUND. THE INVESTIGATION CONCLUDED THAT THE REPORTED FAILURE MAY HAVE BEEN CAUSED BY INCORRECT ASSEMBLY OF THE SUTURE WING TO THE HUB DUE TO OPERATOR ERROR. RETRAINING OF OPERATORS HAS BEEN COMPLETED. PRODUCT DESIGN VERIFICATION/ VALIDATION TESTING HAS BEEN PERFORMED. SUTURE WING INTEGRITY WAS TESTED IN ACCORDANCE WITH EN ISO 10555-1:2013+A1:2017 INTRAVASCULAR CATHETERS - STERILE, SINGLE-USE CATHETERS PART 1: ANNEX B, AND USING THE ZWICK TENSILE TESTER AFTER TRANSIT CONDITIONING AND WHEN PROCESSED THROUGH TWO (2) EO STERILIZATION CYCLES. ALL SAMPLES TESTED IN THIS PROTOCOL MET THE ACCEPTANCE CRITERIA FOR SUTURE WING INTEGRITY.

    Additional Manufacturer Narrative · 0

    WE ARE CURRENTLY WAITING FOR THE DEVICE TO BE RETURNED FOR EVALUATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DISCONNECTION FROM THE CATHETER OF THE FASTENING FLAP OF THE STITCHES WITH PARTIAL REMOVAL OF THE SAME AND NEED FOR NEW POSITIONING WITH TEMPORARY INTERRUPTION OF THE RENAL REPLACEMENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396099 12FX20CM STRAIGHT TPL LMN TRIPLE LUMEN CATHETER MPB MEDICAL COMPONENTS, INC. ART1220S MPTS640

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Required Intervention