BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMALE NON-VENTED LUER LOCK COVER

    MDR report key: 3243270 · Received July 12, 2013

    Report

    Report Number
    2025816-2013-00053
    Event Type
    Other
    Date Received
    July 12, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ICU MEDICAL MANUFACTURES TWO SEPARATE ACCESSORY DEVICES, LIST #42415-01 CONFIGURED WITH FEMALE LUER LOCK AND LIST #42411-01 CONFIGURED WITH A MALE LUER LOCK. (B)(4). THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG BUILD PROCESSES. A THOROUGH INVESTIGATION OF THE AFFECTED COMPONENT INVENTORY RECORDS, KITTING RECORDS, ASSY WORK ORDERS, LINE CLEARANCES, PACKAGING OPERATIONS, LABEL ACCOUNTABILITY RECORDS SHOWED NO DISCREPANCIES AND NO REJECTION DOCUMENTS. THE MFR INVENTORY RECORDS SHOW THE 42415-01 SUB ASSY (B)(4) QUANTITIES WERE CORRECT AND WERE THE ONLY COMPONENT LOT AVAILABLE IN STOCK. BASED ON THE INVESTIGATIONS PERFORMED THUS FAR, THE REPORTED ISSUE HAS NOT BEEN CONFIRMED AS OF THIS DATE.

    Description of Event or Problem · 1

    FDA/MEDSUN REPORT RECEIVED REPORTING LIST # 42415-01 FEMALE NON-VENTED LUER LOCK COVER WAS INCORRECTLY LABELED. THE REPORT STATES "PRODUCT PACKAGED AS FEMALE NON-VENTED LUER LOCK COVER WHEN THEY ARE MALE NON-VENTED LUER LOCK COVERS. BOTH THE BOX AND THE INDIVIDUAL PACKAGE HAVE THE INCORRECT LABELING..." THERE WAS NO PT INVOLVEMENT. MULTIPLE ATTEMPTS BY THE MFR TO FOLLOW-UP WITH THE FACILITY/MEDSUN REPORTER HAVE TO DATE BEEN UNSUCCESSFUL. ALTHOUGH REQUESTED, THE SUSPECT DEVICES WERE NOT RETURNED FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324667 FEMALE NON-VENTED LUER LOCK COVER MONITORING ACCESSORY FPA ICU MEDICAL, INC. 42415-01 2616208

    Patients

    Seq Age Sex Outcome Treatment
    1