BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 LEAD EXTENSION SET W/INTERLINK INJECTION SITE

    MDR report key: 2032827 · Received March 29, 2011

    Report

    Report Number
    6000001-2011-02321
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K915390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED THE SAMPLE FOR THIS COMPLAINT,PRODUCT CODE 2N3341, LOT UNKNOWN. THE SAMPLE ARRIVED OUT OF THE POUCH USED. VISUAL INSPECTION SHOWED THAT THE SAMPLE HAD SEPARATED AT ONE OF THE BIFURCATED Y INLET PORTS. CLOSER VISUAL INSPECTION OF THE SAMPLE UNDER A MICROSCOPE SHOWED THAT THE SEPARATIONS PROBABLY OCCURRED DUE TO THE LACK OF, OR NO SOLVENT BONDING ON THE TUBING ENDS OF THE RETURNED SAMPLES. THE REMAINING BOND JUNCTIONS OF THE SAMPLE WERE THEN INSPECTED FOR INTEGRITY. ALL REMAINING BONDS IN THE SAMPLE PASSED THE PULL TEST REQUIREMENTS. A BATCH REVIEW FOR THE ACTUAL LOT COULD NOT BE DONE AS THE LOT NUMBER WAS NOT PROVIDED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOTS (R10G07016, R09O14055, R10K03133, R09K13143, R10J07045). NO DEVIATIONS WERE FOUND IN THE BATCH REVIEW. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT 1 OF 3 FOR THE REPORTED ISSUE. DURING A FOLLOW CALL TO THE CUSTOMER ON (B)(4) 2011 THE UNIT MANAGER CONFIRMED THAT SHE RECEIVED THE SAMPLE RETURN KIT AND HAS PUT THE SAMPLES IN THE MAIL (TO RETURN TO BAXTER FOR EVALUATION). SHE REPORTED THAT SHE HAS SUBMITTED A FACILITY MED WATCH FOR EACH OF THE ALLEGED SEPARATIONS (3) WHICH CONTAIN ANY ADDITIONAL INFORMATION THAT SHE MAY HAVE HAD REGARDING THE INCIDENTS. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(4) 2011 A BAXTER SALES REPRESENTATIVE CONTACTED CORPORATE PRODUCT SURVEILLANCE TO REPORT THAT IN (B)(6) 2011 THAT WHILE A CUSTOMER WAS USING A 3-LEAD EXTENSION SET, WITH A NEWBORN (ON THE BIRTH DAY) A SEPARATION OCCURRED. AN INFUSION OF GENTAMICIN WAS RUNNING AND THE NURSE WAS DISCONNECTING AN UNKNOWN TUBING FROM ONE OF THE Y-CONNECTIONS BECAUSE THE UNKNOWN INFUSION WAS COMPLETED. THAT IS WHEN SHE NOTICED THAT THE TUBING HAD SEPARATED FROM THE Y-COMPONENT BY ONE OF THE FEMALE LUER ADAPTERS . THERE WAS VERY LITTLE BLOOD THAT BACK FLOWED. THE TIMEFRAME IS UNKNOWN. THE BABY IS FINE AND WAS DISCHARGED DAYS LATER. DURING A FOLLOW UP CALL TO THE CUSTOMER ON (B)(6) 2011, THE UNIT MANAGER REPORTED THERE WAS NO DECREASE IN HEMATOCRIT (NUMBERS NOT REPORTED). THE BABY REMAINED STABLE BECAUSE IT WAS ON A WARMER. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 LEAD EXTENSION SET W/INTERLINK INJECTION SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENTAMICIN