BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL MICRO EXT SET W/CL INJ SITE60IN 1.5M LL 0.5ML STERILE NON

    MDR report key: 1961458 · Received January 14, 2011

    Report

    Report Number
    6000001-2011-00272
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL INFORMATION. THE SAMPLE WAS RECEIVED FOR EVALUATION ON (B)(4) 2011. AN ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. A VISUAL EXAMINATION OF THE SAMPLE REVEALED THE MALE LUER CONNECTOR WAS BROKEN INSIDE OF THE LUER LOCK. THE CUSTOMER CONFIRMED THAT KELLY CLAMPS WERE USED BECAUSE IT IS NOT POSSIBLE TO MANUALLY DISCONNECT THE TWO PARTS. THEREFORE, THE ROOT CAUSE OF BROKEN LUER LOCK WAS THE USE OF THE KELLY CLAMP. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(6) AN UNKNOWN NUMBER OF CLEARLINK MICROBORE EXTENSION SETS IN WHICH "THE MALE ENDS OF THE MICROBORE TUBING EXTENSION SET IS BREAKING OFF IN THE FEMALE ENDS OF THE CLEARLINK LEVER LOCKS AND FLO-LINK LEVER LOCKS." THE CONDITION OCCURRED DURING PATIENT USE. 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 MICRO EXT SET W/CL INJ SITE60IN 1.5M LL 0.5ML STERILE NON SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE

    Patients

    Seq Age Sex Outcome Treatment
    1 FLO-LINK LUERS| CLEARLINK LUERS