BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE CLEAR CONNECTOR

    MDR report key: 3973096 · Received June 5, 2014

    Report

    Report Number
    2025816-2014-00058
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES: METHOD - THE MICROCLAVE IS FDA CLEARED (510 (K) 100576) AS A STAND ALONE DEVICE AND, IN CONNECTION WITH PRESSURE RATED TUBING SETS, FOR USE IN POWER INJECTOR PROCEDURES. THE DEVICES WILL TOLERATE A MAXIMUM OF 400 PSIG OR A FLOW RATE OF 10 ML/SEC OF ROOM TEMPERATURE CONTRAST MEDIA. ACTUAL INFUSION PRESSURES REQUIRED TO DELIVER THE DESIRED VOLUME OF CONTRAST MEDIA ARE TYPICALLY FAR LESS THAN THE MAXIMUM 400 PSIG. THE TABLE BELOW ILLUSTRATES THE TYPICAL PRESSURE REQUIRED TO DELIVER CONTRAST MEDIA THROUGH A STAND ALONE MICROCLAVE. PRESSURES WILL INCREASE WHEN USED IN CONJUNCTION WITH AN EXTENSION SET AND WILL VARY DEPENDING ON THE INTERNAL DIAMETER AND LENGTH OF THAT TUBING. INFUSION PRESSURE FLOW RATE: 50 PSIG >10 ML/SEC; 95 PSIG >12 ML/SEC. A 2013 -2014 YTD QUERY/REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST #/SIMILAR ISSUE WAS PERFORMED. THE RESULTS RECORDED NO ADD'L REPORTS OR DEVICE RETURN INVESTIGATIONS IDENTIFYING A DESIGN. MFG RELATED NON-CONFORMANCE. FINDINGS: THE SET-UP DEVICE INFO INCLUDING THE IDENTITY OF THE TUBING SET/CONFIGURATION THAT THE MICROCLAVE CONNECTORS WERE ATTACHED TO: EQUIPMENT SETTINGS ETC. ARE UNK. THE EXACT CAUSE (S) OF THIS EVENT, PRODUCT ISSUE ARE UNK AT THIS TIME.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING COMPONENT (SILICONE) DAMAGE/LEAKAGE WITH USE OF 12512-01 MICROCLAVE CLEAR CONNECTORS. IT WAS REPORTED THAT "..PT FROM A MED SURG FLOOR SENT TO RADIOLOGY FOR A CT SCAN..DON'T KNOW WHAT KIND OF CATHETER.. MICROCLAVE CLEAR MAP WAS CONNECTED TO A POWER INJECTOR.. THE CONTRAST WAS INJECTED VIA ONE CAP AND IT "SPRAYED OUT" THE OTHER CAP ALL OVER THE PT.. THE SILICONE SEAL WAS FOUND PROTRUDING OUTSIDE THE OPENING OF THE MICROCLAVE.. SPILLING CONTRAST WAS A RESULT OF THE SILICONE SEAL PROTRUDING FROM THE CASING.. THERE WAS NO PT HARM BUT THERE WAS A DELAY IN THERAPY." ADD'L RELEVANT USAGE, EVENT AND DEVICE STATUS INFO WAS REQUESTED. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE. FINDINGS: THE INVOLVED 12512-01/DEVICE SET UP WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE OF THE REPORTED EVENT, PRODUCT ISSUE IS UNK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328551 MICROCLAVE CLEAR CONNECTOR NEEDLELESS CONNECTOR FPA ICU MEDICAL, INC. 12512-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR SYRINGES, MFG. MODEL/LIST: UNK| CATHETER, EXT. TUBING SETS, MFG. MODEL/LIST: UNK