BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE®

    MDR report key: 6420886 · Received March 21, 2017

    Report

    Report Number
    2523676-2017-00034
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Report Date
    February 22, 2017
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964115998
    PMA / PMN Number
    K140311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). ONE USED SAMPLE OF MATERIAL # 415122 WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED A CRACK ON THE FEMALE LUER. THE SAMPLE WAS FUNCTIONALLY TESTED FOR LEAKAGE PER INTERNAL SPECIFICATIONS FAILING RESULTS. THE RETURNED PRODUCT CONFIRMED THE REPORTED DEFECT OF LEAKAGE. B. BRAUN MEDICAL INC. HAS PREVIOUSLY INITIATED A CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) TO CHANGE THE CARESITE LUER THREAD DESIGN TO HELP WITHSTAND THE STRESSES APPLIED DURING ACCESS OF THE VALVE. IN ADDITION TO THE DESIGN CHANGE, THE MOLD PROCESS PARAMETERS WERE CHANGED TO HIGHER PACK PRESSURES IN ORDER TO PROVIDE ADDITIONAL STRENGTH TO THE INLET PORT OF THE VALVE TO RESIST CRACKING. B. BRAUN MEDICAL INC. IS CONTINUING TO INVESTIGATE AND ADDRESS INCIDENTS INVOLVING CRACKING AND LEAKING OF THE CARESITE WHICH PROVIDES FOR ROOT CAUSE INVESTIGATION AND CORRECTIVE ACTION. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: UNABLE TO FLUSH THE CARESITE VALVE ON THE PATIENT'S PERIPHERAL IV. BLOOD CONTINUED TO STREAM OUT OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205233 CARESITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061518773 04046964115998

    Patients

    Seq Age Sex Outcome Treatment
    1