BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK SYS NON-DEHP ADMINSET W/SUO-VENT SPIKE

    MDR report key: 1983742 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00830
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THAT THE BOTTOM CONNECTOR AT THE FILTER HAD BEEN BROKEN. HOWEVER, THE CAUSE OF THIS BROKEN CONNECTION WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERLINK SYSTEM ADMINISTRATION SET THAT HAD A LEAK. ACCORDING TO THE REPORT, A LEAK FROM THE FILTER WAS OBSERVED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK SYS NON-DEHP ADMINSET W/SUO-VENT SPIKE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE S09L07085R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION