BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2250879 · Received September 16, 2011

    Report

    Report Number
    6000001-2011-25085
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE COLLAR OF THE LUER LOCK HAD STEPPED BACKWARDS ALONG THE TUBING. THE COLLAR WAS MOVED FORWARD AND CONNECTED TO A STOPCOCK AND CLICKED. THE LUER LOCK COULD BE DETACHED WITHOUT DIFFICULTIES. HENCE REPORTED PROBLEM WAS NOT CONFIRMED. BASED ON SIMILAR ISSUES AND SAMPLE ANALYSIS, IT IS TO BE STATED THAT ONCE THE LUER LOCK HAS BEEN ROTATED AND ACTIVATED, THE ROTARY COMPONENT IS LOCKED IN THE FORWARD POSITION AND THIS THEN PROVIDES AN AUTOMATIC EJECT FEATURE ON DISCONNECTION. IF THE LUER LOCK IS NOT ROTATED UNTIL IT IS ACTIVATED, THE SELF EJECTING FEATURE WILL NOT WORK WHICH MIGHT MAKE THE LUER LOCK MORE DIFFICULT TO DISCONNECT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. AS PART OF THIS CORRECTIVE ACTION A SLIGHT DESIGN CHANGE HAS BEEN DONE ON THE LUER TO PREVENT THE ROTATING COLLAR FROM OVERRIDING THE NOTCHES ON THE LUER WHILE UNSCREWING THE LUER TO DISCONNECT FROM THE FEMALE LUER DEVICES. FURTHERMORE A DEPICTION WILL BE ADDED ON THE POUCH TO REMIND THE USER ON THE CLICK FUNCTION. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS 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

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT ON (B)(6) 2011 WHEN REMOVING A BAXTER (B)(4) ADMIN SET THE DISTAL LUER BROKE IN THE CATHETER. A PATIENT IS INVOLVED. THERE IS NO CLINICAL CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER