BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3830650 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16839
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEIR INTERLINK BURETROL ADMINISTRATION SET WAS "FALLING APART" AND THAT THE CHAMBER APPEARED "CROOKED". IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT OR PATIENT IMPACT ASSOCIATED WITH THIS REPORT, THOUGH NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308251 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL DR13L03039

    Patients

    Seq Age Sex Outcome Treatment
    1