BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM CONTINU-FLO4 WAY STOPCOCK EXT SET

    MDR report key: 2874060 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07364
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. THE LOT NUMBER IS KNOWN AND A BATCH REVIEW WILL BE PERFORMED. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING THE VISUAL INSPECTION. THE ROOT CAUSE WAS NOT IDENTIFIED. THIS ISSUE HAS BEEN ESCALATED TO CAPA. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    AN EMAIL WAS RECEIVED FROM A CLINICAL SERVICES MANAGER (CSM) WHO STATED THAT A REGISTERED NURSE (RN) REPORTED HAVING PROBLEMS WITH THE STOP COCK CONNECTIONS IN THEIR ANESTHESIA SET COMING APART AND LEAKING. THE NURSING STAFFS ARE TIGHTENING THE CONNECTIONS PRIOR TO PRIMING THE SET. LOT UR12H16062 IS FROM ONE OF THE SETS. RN IS CONCERNED ABOUT SAFETY AS THEY COULD END UP LOSING THE IV SITES. THE CSM HAVE PERFORMED FOLLOW UP AND REINFORCED THE NEED TO TIGHTEN THE CONNECTIONS PRIOR TO PRIMING THE TUBING. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE RN LEFT A MESSAGE FOR PRODUCT SURVEILLANCE ON (B)(6) 2012 INDICATING THAT SHE SPOKE WITH HER STAFF AGAIN TODAY AND THEY ARE CONTINUING TO FIND LEAKING AT BOTH SIDES OF THE STOP COCK (DISTAL AND PROXIMAL ENDS). SHE SAID THE STAFF IS RE-TIGHTENING THEM AND SOME ARE STILL LEAKING AND HAVE TO TIGHTEN THEM EVEN MORE. SHE SAID THE FRUSTRATION WAS HAVING TO TIGHTEN EACH SET SINCE THEY COME LOOSE FROM THE PACKAGE AND THEY HAVEN'T HAD THAT PROBLEM UNTIL RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM CONTINU-FLO4 WAY STOPCOCK EXT SET STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR12H16062

    Patients

    Seq Age Sex Outcome Treatment
    1