BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2180619 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-15091
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THE COLLAR OF THE LUER LOCK (LUER RING) HAD STEPPED BACK ALONG THE TUBING. CLOSE VISUAL INSPECTION REVEALED THAT THE COLLAR HAD A CRACK. NO FURTHER TESTING COULD BE PERFORMED. BASED ON SIMILAR ISSUES, 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. THE ROOT CAUSE OF THE REPORTED CONDITION WAS UNDETERMINED. BAXTER SHALL KEEP MONITORING THESE EVENTS DURING QUALITY REVIEWS. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. 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) REGARDING A BAXTER DEHP FREE SOLUTION ADMINISTRATION SET THAT WAS IMPOSSIBLE TO DISCONNECT. THE MOBIL LUER RING SEPARATED FROM THE LUER LOCK AND THE MALE LUER STAY BLOCKED IN THE CATHETER. 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 11B18V471

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER