BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGO

    MDR report key: 3252635 · Received July 18, 2013

    Report

    Report Number
    2025816-2013-00039
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    December 10, 2012
    Report Date
    March 6, 2013
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFRS INVESTIGATION: DEVICE RETURN: TWO (2) USED D1000 TEGO CONNECTORS, AND FOUR (4) PKGD. D1000 TEGO CONNECTORS FROM POTENTIAL AND OR SUSPECT LOT#¿S 2497452 AND 2389878; ONE (1) PKGD. BD 10ML SYRINGE. VISUAL ANALYSIS RECORDED NO OBVIOUS ABNORMALITIES WITH THE RETURNED PACKAGE TEGO CONNECTORS. VISUAL INSPECTION OF THE RETURNED USED TEGO CONNECTORS RECORDED ONE OF THE TWO TEGO CONNECTORS SLIT WAS TORN/DAMAGED. NO VISUAL DEFECTS WITH THE SECOND USED TEGO CONNECTOR. ENGINEERING TESTING AND ANALYSIS TO THE APPLICABLE TEGO PRODUCT SPECIFICATIONS WERE CONDUCTED. THE RESULTS RECORDED NO PERFORMANCE ISSUES AND OR OUT OF SPECIFICATION CONDITIONS WITH FOUR PKGD TEGO CONNECTORS. THE REPORT DOCUMENTS ONE OF THE TWO RETURNED USED TEGO CONNECTORS FAILED LEAK TESTING. THE ENGINEERING ANALYSIS REPORT IDENTIFIED THE SOURCE OF THE LEAKAGE WAS DUE TO THE TEAR IN THE CORNER OF THE TEGO SLIT. THE SECOND RETURNED TEGO CONNECTOR PASSED THE PERFORMANCE TESTING. THERE WERE NO RECORDED EXTERNAL LEAKAGES. ADD¿L EVALS: A REVIEW OF THE CURRENT MOLDING, ASSEMBLY PROCESSES AND APPLICABLE TOOLING AND EQUIPMENT WAS CONDUCTED TO DETERMINE IF ANY FIXTURES, EQUIPMENT OR MATERIAL HANDLING CONDITIONS COULD POTENTIALLY CONTRIBUTE TO SLIT DAMAGE. THE RESULTS DID NOT IDENTIFY ANY IN-PROCESS CONTRIBUTING FACTORS. (B)(4). THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG BUILD CYCLES. CONCLUSION: ENGINEERING TESTING AND ANALYSIS CONFIRMED A LEAKAGE FAILURE ATTRIBUTABLE TO COMPONENT DAMAGE ON ONE OF THE TWO RETURNED USED D1000 TEGO CONNECTORS. THE EXACT CAUSE(S) OF THE COMPONENT DAMAGE/TEAR ON THE RETURNED USED D1000 TEGO CONNECTOR CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    INT¿L (B)(6) COMPLAINT REC¿D REPORTING LEAKAGE/COMPONENT DAMAGE ISSUES WITH USE OF D1000 TEGO CONNECTORS. IT WAS REPORTED THAT ¿..ON TWO OCCASIONS THE CLAMP HAS COME UNDONE ON ONE THE LUMENS AND BLOOD HAS LEAKED OUT OVER (PT) CLOTHES. ¿TEGO CONNECTOR SEALS APPEARED DAMAGED¿¿ IT WAS ALSO REPORTED THAT ¿WHEN ATTACHING AN ORAL SYRINGE TO THE OPPOSITE END OF THE DAMAGED CONNECTOR, THE MUM WAS ABLE EASILY PUSH FLUID PAST THE SEAL WITH NO FORCE PUT ON THE PLUNGER. HERE WAS NO REPORTED HARM TO THE PT ON EITHER OCCASIONS HOWEVER STAT DOSES OF ANTIBIOTICS WERE GIVEN TO COVER POTENTIAL INFECTION¿¿ ALTHOUGH REQUESTED, ADD¿L RELEVANT USAGE INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335229 TEGO CONNECTOR FPA ICU MEDICAL INC. D1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR PERMACATH DIALYSIS CATHETER| DIALYSIS TUBING LINE NOI