BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR

    MDR report key: 1925088 · Received December 14, 2010

    Report

    Report Number
    6000001-2010-05784
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION. THE (B)(4) ULTRASITE PRIMARY SET WAS NOT RETURNED. THE SAMPLE ARRIVED SPIKED AND FULLY PRIMED INTO AN EMPTY (B)(4) 50ML CEFAZOLIN SOLUTION BAG. THE SAMPLE WAS REMOVED FROM THE ADMINISTRATION PORT OF THE SOLUTION BAG AND VISUALLY INSPECTED FOR ANY DAMAGE TO THE MALE LUERS. THE LUER WAS THEN ISO GAUGED AND LIQUID LEAK TESTED. VISUAL INSPECTED SHOWED NO OBVIOUS DAMAGE TO EITHER MALE LUER. THE MALE LUER PASSED ISO GAUGING AND PASSED LIQUID LEAK TESTING WITH NO UNSCREWING NOTED DURING THE 45 PSI PRESSURE TEST. BECAUSE THE SAMPLE PASSED THE VISUAL INSPECTION, ISO GAUGING AND LEAK TESTING THE COMPLAINT WILL NOT BE CONFIRMED. THEREFORE, NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE FDA, VIA A USER FACILITY REPORT, WHO NOTIFIED BAXTER CORPORATE PRODUCT SURVEILLANCE THAT A NURSE STARTED A PRE-OP ANTIBIOTIC IV PIGGYBACK WITH THE CLEARLINK SECONDARY MEDICATION SET, THEN LEFT THE ROOM TO GET A BLANKET FOR THE PATIENT. WHEN THE NURSE RETURNED TO THE ROOM, SHE NOTICED A LARGE PUDDLE UNDER THE IV. THE ANTIBIOTIC HAD INFUSED ONTO THE FLOOR. A NEW ANTIBIOTIC AND TUBING WERE OBTAINED AND A NEW PORT ON THE (B)(4) ULTRASITE PRIMARY SET WAS USED. THE NURSE ATTACHED THE IV PIGGYBACK TUBING TO THE NEW PORT AND STARTED A NEW INFUSION OF PRE-OP ANTIBIOTICS. THE NURSE WATCHED THE INFUSION START AND THEN NOTICED THE LUER LOCK SLOWLY START UNSCREWING FROM THE PORT, BECOMING FASTER AS SHE WATCHED. THE NURSE STOPPED THE LUER LOCK AND RE-SCREWED IV PIGGYBACK IN AND THEN WATCHED AGAIN AS THE LUER LOCK BEGAN UNSCREWING. THE NURSE HELD THE LUER LOCK IN PLACE AS THE ANTIBIOTICS RAN IN. 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 CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) ULTRASITE PRIMARY SET