BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-LINK LUER ACTIVATED DEVICEWITH SILVER ANTIMICROBIAL COAT

    MDR report key: 1914943 · Received December 6, 2010

    Report

    Report Number
    6000001-2010-05549
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K081289
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED TO BE RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. SHOULD THE SAMPLE BE RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INITIAL EVALUATION WAS COMPLETED BY THE (B)(4) PLANT. FOUR USED SAMPLES WERE RECEIVED, LOT NUMBER UNKNOWN. DURING VISUAL INSPECTION A BROKEN THREAD AREA IN THE V-LINK LUER ACTIVATED DEVICE WAS OBSERVED. THE REPORTED CONDITION WAS CONFIRMED. THE SAMPLES WERE SENT TO THE FAILURE ANALYSIS LAB (FAL) FROM THE (B)(4) PLANT FOR A SECOND EVALUATION. THREE OF THE FOUR SAMPLES ARRIVED ATTACHED TO THE FEMALE LUERS OF THE B. BRAUN TRI-PORT CONNECTOR (CHRISTMAS TREE). VISUAL INSPECTION OF TWO OF THE V LINK SAMPLES SHOWED THAT THE FEMALE AND GLAND ENDS WERE CRACKED AND BROKEN. VISUAL INSPECTION OF THE B. BRAUN TRI-PORT CONNECTOR SHOWED THE MALE LUER AND ONE OF THE FEMALE LUERS WERE CRACKED AND BROKEN. THE V-LINK BREAKAGE APPEARED TO HAVE A DIRECTIONAL PATTERN WITH STRESS MARKINGS. RESULTS OF EVALUATION CONFIRMED THE DEFECT AS A CRACKED AND BROKEN SECTION OF THE GLAND SIDE THREAD AREA OF THE V-LINK. THE ROOT CAUSE CANNOT BE IDENTIFIED UPON COMPLETION OF BAXTER'S INVESTIGATION. 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 AXTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY CLINICAL SPECIALIST, INDICATES: THERE IS NO INFORMATION AVAILABLE REGARDING LOT NUMBERS FOR THIS PRODUCT. THE PRODUCT WAS NOT CONNECTED TO A "CHRISTMAS TREE". IT WAS CONNECTED TO A TRIPLE LUMEN CATHETER VIA THE V-LINK. THE TUBING WAS CONNECTED TO THE BAG (MEDICATION) WITH A CLEAR LINK Y SET. THE "CHRISTMAS TREE" HAD A B. BRAUN VALVE ON IT WHICH IS THE WAY IT COMES FROM THE MANUFACTURER. NO PRESSURE INJECTOR WAS USED. THE CRACKING WAS NOT SEEN UNTIL THE SAMPLE WAS REMOVED FROM THE PATIENT. THE FACILITY HAS NO ISSUES CONNECTING THE MALE LUERS TO THE GLAND SIDE OF THE V-LINK INJECTION SITES. ALL THE FACILITY PORTS AND LUMENS HAVE V-LINKS ON THEM EXCEPT IN SURGERY WHEN THE CENTER ONE IS FOR CONTINUOUS INTRAVENOUS FLUIDS TO PREVENT ACCIDENTAL DISCONNECTS AND THE RISK OF AIR EMBOLI. THE REQUEST FOR AN ON SITE VISIT WILL BE CONSIDERED.

    Description of Event or Problem · 1

    THE PT WAS NOT ABLE TO ADJUST STIMULATION. THE ICON "CALL YOU DOCTOR" DISPLAYED. A POWER ON RESET (POR) OCCURRED. THE PT WAS ABLE TO CLEAR THE POR WHICH RESOLVED THE ISSUE. THE NEUROSTIMULATOR (INS) WAS 50-70% FULL AND THE PT HAD EXCELLENT COUPLING EFFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) THAT THE LUER THREADING OF A V-LINK LUER WAS BROKEN WHILE CONNECTED TO AN UNKNOWN ARROW INTERNATIONAL CATHETER DURING A PATIENT INFUSION OF DOPAMINE (DOSE, RATE AND CONCENTRATION UNKNOWN). A COLLEAGUE PUMP WAS BEING USED. REPORTEDLY, THERE IS NO ALLEGATION OF A PUMP ISSUE RELATED TO THIS EVENT. IT IS UNKNOWN AT WHAT POINT OF THE INFUSION THIS EVENT OCCURRED. THE PATIENT REPORTEDLY BECAME HYPOTENSIVE (BLOOD PRESSURE LEVEL UNKNOWN). THE PART OF THE V-LINK CONNECTED TO THE TUBING WAS BROKEN. THE V-LINK WAS ATTACHED TO AN UNKNOWN BLUE ANTI-REFLUX VALVE, WHICH WAS CONNECTED TO A B-BRAUN TRI-PORT CONNECTOR ("CHRISTMAS TREE"). THE TRI PORT CONNECTOR HAD MULTIPLE LIFE SUSTAINING DRIPS SET UP AND INFUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-LINK LUER ACTIVATED DEVICEWITH SILVER ANTIMICROBIAL COAT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DOPAMINE