BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-FLOW T-CONN W/LL & 1 VLV PORT

    MDR report key: 10252059 · Received July 9, 2020

    Report

    Report Number
    9616066-2020-02139
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 19, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    UDI-DI
    10885403234873
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT, THE TUBING WAS LEAKING AT THE COLLAR. RECEIVED FROM THE CUSTOMER WAS A USED EXTENSION SET MODEL: 20043E, LOT: 20037273. A STANDALONE SMARRTSITE ADAPTER MODEL: 2000E, LOT: UNKNOWN WAS RECEIVED CONNECTED TO THE FEMALE LUER OF THE T-CONNECTOR SET. THE AS-RECEIVED SET SAMPLE WAS INSPECTED FOR KINKS, HOLES / TEARS IN THE TUBING, OR DAMAGES TO THE COMPONENTS. THERE WAS A CRACK ALONG THE SIDE OF THE SET'S FEMALE LUER LOCK P/N: 630-01367 COMPONENT (CAVITY 8). THE CRACK WAS OBSERVED TO BE APPROXIMATELY OPPOSITE THE INJECTION GATE ON THE LUER COMPONENT. THE LOCATION OF THE INJECTION GATE (BELOW THE WINGS / TABS) INDICATES THAT THIS FEMALE LUER WAS MANUFACTURED AFTER THE CHANGE ORDER (CO#: 1110016) THAT MOVED THE INJECTION GATE TO A LOWER LOCATION TO HELP MITIGATE AND PREVENT FEMALE LUER CRACKS. NO TOOL MARKINGS WERE OBSERVED AROUND THE OBSERVED DAMAGED AREA. NO OTHER DAMAGE OR ISSUE WAS OBSERVED. ALTHOUGH DAMAGE WAS OBSERVED, FUNCTIONAL TESTING WAS PERFORMED. FLUID FROM A LAB SYRINGE WAS PUSHED THROUGH. THE FLUID LEAKED FROM THE CRACK. NO OTHER LEAK WAS OBSERVED. EQUIPMENT USED (INSPECTION PERFORMED ON 2-SEP2020): RAM OPTICAL INSTRUMENTATION / EQ08204 / CALIBRATION DUE DATE 5-FEB-2021. DEVICE HISTORY RECORD FOR MODEL: 20043E, LOT: 20037273 SHOWS THAT THE SET WAS MANUFACTURED ON 28 MARCH 2020 WITH A TOTAL OF (B)(4) UNITS. THERE WERE NO QN¿S (QUALITY NOTIFICATION) ISSUED DURING THE PRODUCTION BUILD OF THIS LOT FOR THE FAILURE MODE REPORTED. THE CUSTOMER'S REPORT THAT THE TUBING WAS LEAKING AT COLLAR WAS CONFIRMED. THE ROOT CAUSE OF THE FEMALE LUER CRACK WAS IDENTIFIED TO BE A RESULT OF INTERNAL STRESSES CREATED DURING THE MANUFACTURING PROCESS THAT MAKE IT MORE SUSCEPTIBLE TO CHEMICAL/MECHANICAL ATTACKS AND THE PVC MATERIALS USED IN THE NEW FEMALE LUER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HI-FLOW T-CONN W/LL & 1 VLV PORT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM NEEDING A CASE NUMBER FOR ABOVE MENTIONED DEVICE. WHEN PULLED FORM PACKAGING AND PRIMED FOR PATIENT USE, FOUND TO BE LEAKING AT COLLAR. I HAVE THE TIME AND THE PACKAGING. WAS NOT ACTUALLY USED IN PATIENT CARE AS ANOTHER ITEM WAS OBTAINED FOR USE. DATE OF EVENT IS ON (B)(6).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HI-FLOW T-CONN W/LL & 1 VLV PORT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM NEEDING A CASE NUMBER FOR ABOVE MENTIONED DEVICE. WHEN PULLED FORM PACKAGING AND PRIMED FOR PATIENT USE, FOUND TO BE LEAKING AT COLLAR. I HAVE THE TIME AND THE PACKAGING. WAS NOT ACTUALLY USED IN PATIENT CARE AS ANOTHER ITEM WAS OBTAINED FOR USE. DATE OF EVENT IS JUNE 8TH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715725 HI-FLOW T-CONN W/LL & 1 VLV PORT SET, EXTENSION, INTRAVASCULAR FPA CFN MEXICO 215 SA DE CV 20043E 20037273 10885403234873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200608.| 20200608.