BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE 6 INCH EXT VLV

    MDR report key: 10570613 · Received September 22, 2020

    Report

    Report Number
    9616066-2020-02864
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 30, 2020
    Report Date
    September 2, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203011952
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 09/10/2020. INVESTIGATION CONCLUSION : THE CUSTOMER REPORTED ¿WHEN A SYRINGE IS SCREWED ONTO THE LUER LOCK, THE PLUNGER IS NOT DEPRESSING ENOUGH TO ALLOW FLUID THROUGH¿. RECEIVED FROM THE CUSTOMER WAS ONE USED EXTENSION SET MODEL 20039E LOT 20075476 WITH ITS ORIGINAL PACKAGE. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO ABNORMALITIES WERE OBSERVED DURING VISUAL INSPECTION. TO PREPARE THE SET FOR FUNCTIONAL TESTING A LAB EXTENSION SET WAS ATTACHED TO THE SET¿S MALE LUER TO TEST THE CONNECTION. AN 18 GAUGE BLUNT CANNULA WAS ATTACHED TO THE END OF THE LAB EXTENSION SET TO CLOSELY SIMULATE HOW THE SET WOULD BE USED IN THE FIELD. FUNCTIONAL TESTING WAS PERFORMED BY FILLING A LAB 10ML BD SYRINGE WITH BLUE-DYED WATER AND ATTACHING IT TO THE SET¿S SMARTSITE. THE SYRINGE PLUNGER WAS DEPRESSED AND THE FLUID WAS OBSERVED TO FLOW THROUGH THE SET AND PRIMED COMPLETELY. THE SYRINGE WAS REPEATEDLY CONNECTED AND DISCONNECTED FROM THE SMARTSITE WITH THE SYRINGE PLUNGER REPEATEDLY BEING DEPRESSED. NO OCCLUSIONS, LEAKING, OR OTHER ISSUES WERE OBSERVED DURING TESTING. THE DEVICE HISTORY RECORD FOR EXTENSION SET MODEL 20039E LOT 20075476 WAS PERFORMED. THE SEARCH SHOWED A TOTAL OF 12,000 UNITS IN 1 LOT WERE BUILT ON 07 JULY 2020. THERE WERE NO RELATED QN¿S (QUALITY NOTIFICATIONS) ISSUED DURING THE PRODUCTION BUILD OF THIS SET FOR THE FAILURE MODE REPORTED FOR THE GIVEN TIME FRAME. THE CUSTOMER¿S REPORT OF WHEN A SYRINGE IS SCREWED ONTO THE LUER LOCK, THE PLUNGER IS NOT DEPRESSING ENOUGH TO ALLOW FLUID THROUGH WAS NOT CONFIRMED ON EXTENSION SET MODEL 20039E. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF THE PLUNGER IS NOT DEPRESSING ENOUGH TO ALLOW FLUID THROUGH COULD NOT BE DETERMINED AS WE WERE UNABLE TO REPLICATE THE REPORTED EVENT DURING FUNCTIONAL TESTING. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD EXTENSION SET SMALLBORE TUBING(WE REFER TO THIS ITEM AS "J-LOOPS") WE HAVE BEEN GETTING AT OUR ER HAVE BEEN NOT WORKING AS WELL AS IN THE PAST. LATELY WHEN A SYRINGE IS SCREWED ONTO THE LUER-LOK, THE BLUE PLUNGER IS NOT BEING DEPRESSED ENOUGH TO ALLOW FLUID TO THRU IT. THE NURSES HAVE BEEN REMOVING THE J-LOOP AND REPLACING IT WITH A NEW ONE, ONLY TO HAVE THE SAME ISSUE. THE J-LOOPS ARE NOT ALL FROM THE SAME BOX OR CASE. I WAS ABLE TO GET THE J-LOOPS TO WORK BY REPEATEDLY SCREWING A SYRINGE ONTO THE LUER-LOK END A COUPLE OF TIMES. I GUESSING THAT IF WE ARE HAVING TROUBLE, THEN ALL YOUR CUSTOMERS WHO USE THESE ARE HAVING TROUBLE. DATE OF FAILURE: AUGUST 30TH.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD EXTENSION SET SMALLBORE TUBING(WE REFER TO THIS ITEM AS "J-LOOPS") WE HAVE BEEN GETTING AT OUR ER HAVE BEEN NOT WORKING AS WELL AS IN THE PAST. LATELY WHEN A SYRINGE IS SCREWED ONTO THE LUER-LOK, THE BLUE PLUNGER IS NOT BEING DEPRESSED ENOUGH TO ALLOW FLUID TO THRU IT. THE NURSES HAVE BEEN REMOVING THE J-LOOP AND REPLACING IT WITH A NEW ONE, ONLY TO HAVE THE SAME ISSUE. THE J-LOOPS ARE NOT ALL FROM THE SAME BOX OR CASE. I WAS ABLE TO GET THE J-LOOPS TO WORK BY REPEATEDLY SCREWING A SYRINGE ONTO THE LUER-LOK END A COUPLE OF TIMES. I GUESSING THAT IF WE ARE HAVING TROUBLE, THEN ALL YOUR CUSTOMERS WHO USE THESE ARE HAVING TROUBLE. DATE OF FAILURE: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033382 SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20075476 07613203011952

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 302995, 20200830| 302995, 20200830