BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 3881749 · Received May 22, 2014

    Report

    Report Number
    2025816-2014-00061
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER VISUAL ANALYSIS OF THE ONE RETURNED USED TEGO COMPONENT DAMAGES DOCUMENTS SEAL TEARS ALONG THE TOP RIM. ALTHOUGH NOT ALWAYS REPEATABLE, PREVIOUS INVESTIGATIONS OF THIS TYPE OF COMPONENT DAMAGES HAVE BEEN REPLICATED WITH OVER TIGHTENING A MATING LUER LOCK DEVICE. THE THREADS OF THE MATING DEVICE WILL AUGER AND TEAR THE SILICONE SEAL OF THE TEGO CONNECTOR. THE REPORT NOTED IF THE MATING DEVICE CONTINUES TO TWIST ON THE TEGO CONNECTOR IT IS AN INDICATION THAT THE MATING DEVICE THREADS HAVE BEEN STRIPPED AND CONTINUED TWISTING CAN TEAR THE TEGO SEAL. ONCE TORN THE TOP OF THE SEAL CAN POTENTIALLY PUSH INSIDE THE BODY OF THE TEGO CONNECTOR DURING ACCESS. EVALS OF THE RETURNED MATING DEVICE SAMPLES AND THE PACKAGED TEGO CONNECTOR WERE CONDUCTED. THOUGH EACH WAS AGGRESSIVELY CONNECTED MULTIPLE TIMES TO THE TEGO, THE TEARING DAMAGE WAS NOT REPLICATED WITH THE RETURNED DEVICES. A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE REPORTED "POTENTIAL" LOT# 2720733 (MFG DATE 08/2013) SHOWS 28500 UNITS WERE MFG TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG BUILDS. FINDINGS: VISUAL ANALYSIS OF THE "AS-REC'D" USED TEGO CONNECTOR CONFIRMED COMPONENT DAMAGES THAT WOULD RESULT IN LEAKAGE. ALTHOUGH THE EXACT CAUSE(S) OF THE EVENT ARE UNK AT THIS TIME, THE DATA DOES SUGGEST TECHNIQUE RELATED/USAGE CONDITIONS CONTRIBUTED TO THE EVENT/PRODUCT ISSUE.

    Description of Event or Problem · 1

    COMPLAINT REC'D CONCERNING LEAKAGE/COMPONENT DAMAGE ISSUES WITH USE OF D1000 TEGO CONNECTORS, LOT # UNK. THE INFO REC'D REPORTS "... ISSUE WITH THE TEGO CAP ON A DIALYSIS LINE IN PICU... IT LOOKS LIKE THE RUBBER CAP ON THE TIP FLIPPED INSIDE THE CAP. THE NURSE SAID WHEN SHE OPENED THE LINE; BLOOD CAME THROUGH THE CAP (WHICH IS AN INFECTION RISK)... NO HARM TO PT OR NURSE..." THERE IS WAS NO PT INJURY AND OR ADVERSE CONSEQUENCES. DEVICE RETURN: ONE (1) USE D1000 TEGO AND ONE (1) PACKAGED LOT# 2720733. ALSO REC'D. (1) PKGD. CAREFUSION ALARIS EXT. SET; (1) PKGD. BD 10ML PREFILL SALINE SYRINGE, (1) PKGD. BD VACUTAINER, (1)PKGD. BARD IPA SITE SCRUB. VISUAL INSPECTION (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE RESULTS RECORDED VARIOUS COMPONENT DAMAGES MOST NOTABLY ALONG THE TOP RIM OF THE TEGO CONNECTOR SEAL. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED MATING DEVICES/MATING COMPONENTRY. THE RESULTS RECORDED NO DIMENSIONAL INCOMPATIBILITIES WITH THE MATING DEVICE MALE LUER TAPERS AND A MALE LUER THREAD INSIDE DIAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304854 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL INC. D1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR BARD IPA SITE SCRUB| BD 10ML PREFILL SALINE SYRINGE| BD VACUTAINER CAREFUSION ALARIS EXT. SET