BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGO

    MDR report key: 3252665 · Received July 18, 2013

    Report

    Report Number
    2025816-2013-00038
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    October 31, 2012
    Report Date
    March 6, 2013
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFRS INVESTIGATION: DEVICE RETURN: ONE (1) USED D1000 TEGO CONNECTOR WAS RETURNED FOR ANALYSIS AND INVESTIGATION. THE REQUESTED MATING AND ACCESS DEVICES WERE NOT RETURNED. VISUAL ANALYSIS (PRE AND POST DECONTAMINATION) RECORDED THAT BLOOD WAS VISIBLE ON BOTH THE INSIDE AND OUTSIDE OF THE SILICONE SHEATH. NO OTHER OBVIOUS COMPONENT DAMAGES WERE DETECTED. FUNCTIONAL AND PERFORMANCE TESTING TO THE APPLICABLE TEGO PRODUCT SPECIFICATIONS WAS CONDUCTED. FUNCTIONAL AND PERFORMANCE TESTING RESULTS RECORDED THE RETURNED D1000 DEVICE MET THE APPLICABLE PERFORMANCE REQUIREMENTS. ADD¿L EVALS: THE D1000 CONNECTOR WAS DISASSEMBLED AND EXAMINED UNDER MAGNIFICATION. THE RESULTS RECORDED EVIDENCE OF BLOOD FIBRIN BETWEEN THE TEGO SEAL AND THE POST WHICH COULD HAVE RESULTED IN INTERNAL LEAKAGE. CONCLUSION: THOROUGH TESTING OF THE RETURNED USED D1000 TEGO CONNECTOR RECORDED NO FUNCTIONAL AND OR PERFORMANCE ISSUES. THE REPORTED LEAKAGE ISSUE WAS NOT REPLICATED. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN PROVIDED TO THE DISTRIBUTOR AND REPORTING FACILITY FOR THEIR REVIEW AND RECORDS ALONG WITH A RECOMMENDATION THAT THE PRODUCT REPS CONDUCT TRAINING AND IN-SERVICING OF THE INVOLVED FACILITY STAFF. THE MFR HAS ALSO PROVIDED ADD¿L LITERATURE/WHITE PAPERS ON ACCEPTED CLINICAL FLUSHING AND USAGE PROTOCOLS.

    Description of Event or Problem · 1

    INT¿L (B)(6) COMPLAINT REC¿D CONCERNING LEAKAGE INCIDENT WITH USE OF D1000 TEGO CONNECTORS. IT WAS REPORTED THAT HOMECARE PTS. TEGO WAS LEAKING AND THAT ¿..PT HAS TO COME BACK TO THE (HOSPITAL) CENTER. THE TEGO HAS A BLOOD LEAK (DRESSING FULL OF BLOOD).¿ THE INVOLVED SET-UP/MATING DEVICES IDENTIFIED AS MECOMP CATHETER AND FRESENIUS BLOOD LINES. THE TEGO CONNECTOR WAS REPORTEDLY IN USE APPROX 5 DAYS WHEN THE INCIDENT OCCURRED. ALTHOUGH ADD¿L INFO REQUESTED, NO RESPONSES WERE REC¿D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335263 TEGO CONNECTOR FPA ICU MEDICAL INC. D1000 2466314

    Patients

    Seq Age Sex Outcome Treatment
    1 NI FRESENIUS BLOOD LINES| MEDCOMP CATHETER