BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLAVE CONNECTOR

    MDR report key: 2393981 · Received December 22, 2011

    Report

    Report Number
    2025816-2011-00085
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L NOTE: THE FACILITY HAS INDICATED THEY ARE FILLING A UFMW AND PROVIDED THEIR REF. NUMBER. UFMW "HARD COPIES" REC'D IN MAIL INDICATED THE REPORTED INCIDENTS WERE DOCUMENTED ON TWO SEPARATE (B)(4). ADDITIONALLY SOME DISCREPANCIES NOTED WITH EVENT DATES REPORTED AND EVENT DATES RECORDED ON UFMW.

    Description of Event or Problem · 1

    TWO (2) UFMW REC'D. REPORTING ON-GOING LEAKAGE ISSUE WITH USE OF BARD POWERLOC HUBER NEEDLE SETS AND 11956 CLAVE CONNECTORS. IT WAS REPORTED THAT ON (B)(6) 2011 THERE WERE "TWO MORE CRACKED NEEDLES ... IN BOTH INSTANCES THERE WAS LEAKAGE WHILE BEING FLUSHED WITH NORMAL SALINE AND HAD NORMAL SALINE INFUSION PRIOR TO BEING FLUSHED." ADDITIONALLY TWO MORE INCIDENTS OCCURRED OVER THE (B)(6) WEEKEND STATING "..." "2 MORE INCIDENTS OVER THIS PAST WEEKEND WITH THE POWER LOC NEEDLE AND BLUE CLAVE COMBINATION HAVING A LEAK, SAME PLACE, SAME ISSUE. ... DO NOT HAVE EITHER PORT B/C THEY WERE THROWN IN SHARPS BEFORE THE 2 RN'S REMEMBERED TO SAVE THEM. ONE HAD NS RUNNING AND THE OTHER HAD JUST FINISHED BLOOD AND WAS BEING FLUSHED". THERE WERE NO REPORTED ADVERSE PT/OPERATOR CONSEQUENCES. CLAVE MFGERS ANALYSIS AND INVESTIGATION: THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND INVESTIGATIONS. PREVIOUS INCIDENT AND DEVICE INVESTIGATION CONDUCTED BY BOTH MFGRS OF THE 11956 CLAVE CONNECTORS RECORDED NO PERFORMANCE ISSUES AND OR OUT OF SPEC CONDITIONS. ICU MEDICALS FUNCTIONAL AND PERFORMANCE TESTING CONDUCTED FOR THE PREVIOUSLY REPORTED EVENTS DID REPLICATE LEAKAGE ORIGINATING FROM AXIAL CRACK(S) ON CONNECTOR OF THE BARD - HUBER PLUS NEEDLE SAFETY INFUSION SET THAT WAS RETURNED. CONCLUSION: THE 11956 CLAVE CONNECTOR WAS NOT RETURNED FOR ANALYSIS AND INVESTIGATION. ALTHOUGH THE CLAVE CONNECTOR WAS IN USE THERE WERE NO REPORTED PERFORMANCE ISSUES FOUND WITH THE CONNECTOR. THE EXACT CAUSE OF THE LEAKAGE INCIDENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE CONNECTOR NEEDLELESS CONNECTOR FPA ICU MEDICAL, INC. 11956 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI BARD POWERLOC CLEAR HUBER NEEDLES SAFETY| INFUSION SET