BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX

    MDR report key: 12020887 · Received June 17, 2021

    Report

    Report Number
    3012307300-2021-06204
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    January 5, 2021
    Report Date
    March 7, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10351688518842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. TWENTY-NINE (29) SAMPLES WERE RECEIVED FROM CUSTOMER. WATER/LEAK TEST: RETURNED SAMPLES WERE INSPECTED FOR WATER LEAK TEST AT 20 PSI FOR 30 SEC ACCORDING TO PROCEDURE MTY-QC001 REV.102 AND MTY-M-5 REV. 101 AND MTY-M-181 REV. 102. RESULTS: 6 OUT OF 29 SAMPLES PRESENTED LEAK AT THE SOLVENT BONDING OF STOPCOCK P/N A409G2 AND MALE LUER LOCK P/N 500-010. VISUAL INSPECTION WAS EXECUTED BY UN-AIDED EYE AND UNDER MAGNIFICATION. RESULTS: COMPONENTS SHOWS A LEAK CHANNEL DUE TO A LACK OF SOLVENT DURING BONDING PROCESS. BASED ON VISUAL INSPECTION OF THE SAMPLES, THE MOST LIKELY CAUSE IS A LACK OF SOLVENT DURING RIGID-RIGID BONDING PROCESS. ACTIONS - AWARENESS MEETING WITH OPERATORS AND QUALITY INSPECTORS ABOUT THE FAILURE MODE REPORTED ON THIS COMPLAINT WAS HELD, DOCUMENTED ON FOLIO 13843 COMPLETED ON (B)(6) 2021. AS PART OF IMPROVEMENT ACTIVITIES SOLVENT DISPENSERS WERE IDENTIFIED WITH THE EXPECTED LEVEL OF SOLVENT TO AVOID LACK OF SOLVENT IN THE DIP. COMPLETED ON (B)(6) 2021. COMPLAINT DATA WAS REVIEWED ON (B)(6) 2021 AND AFTER REVIEWING THE COMPLAINTS HISTORY FROM (B)(6) 2018 TO DATE, IT WAS FOUND THAT THESE ARE THE 3RD. TO 8TH. COMPLAINT RELATED TO LEAKING DEFECT ON THE REPORTED CODE: MX448F78MG. PREVIOUS COMPLAINTS CC-0100138 AND C-0100150 WERE NOT CONFIRMED SINCE NO PRODUCT WAS RETURNED FOR INVESTIGATION. NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL EXTENSION SET WAS LEAKING DURING USE WITH IV FLUID WITH NICU PATIENTS. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911924 MEDEX SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. MX448F78MG 4107279 10351688518842

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown