BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2851431 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06146
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. DURING VISUAL INSPECTION AT THE MANUFACTURING FACILITY IT WAS IDENTIFIED THAT THE SAMPLE WAS TORN OPEN; CONFIRMING THE CUSTOMER REPORTED CONDITION. THE ROOT CAUSE HAS BEEN IDENTIFIED TO BE RELATED TO A MANUFACTURING DEFICIENCY. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE AN UNKNOWN AMOUNT OF CLEARLINK Y-TYPE CATHETER EXTENSION SETS IN WHICH, WHEN ATTEMPTING TO PULL THE PACKAGING APART FROM ONE ANOTHER, THE PACKAGES WERE TORN OPEN. THEREFORE, THE STERILITY OF THE PRODUCT WAS COMPROMISED. ACCORDING TO THE REPORT, THE PERFORATION BETWEEN THE TWO PACKAGES WAS NOT AS DEFINED AS NORMAL. THE ALLEGED DEFECT OCCURRED BEFORE USE. THEREFORE, THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS ADMINISTRATION, SET, INTRAVASCULAR FPA BAXTER HEALTHCARE R12H28075

    Patients

    Seq Age Sex Outcome Treatment
    1