BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS CONNECTOR

    MDR report key: 3881750 · Received May 22, 2014

    Report

    Report Number
    2025816-2014-00062
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEERING ANALYSIS OF THE LUER LOCK SYRINGE MALE LUER RECORDS THE BRITTLE CHARACTERISTICS OF THE BREAKAGE SUGGESTS THAT THE MALE LUER WAS WEAKENED MOST LIKELY DUE TO EXPOSURE TO CHEMOTHERAPY DRUG PRIOR TO THE BREAKAGE. ADD'L. ENGINEERING EFFORTS TO RECREATE THE MALE LUER BREAKAGE WITH ONE OF THE 20ML SYRINGES WAS PERFORMED. A FEMALE LUER WAS ATTACHED TO THE END OF THE BD 20ML SYRINGE AND A BENDING FOR CE WAS APPLIED ONE INCH AWAY. IT REQUIRED 19.05 IN-1BS OF BENDING TORQUE TO SEPARATE THE MALE LUER FROM THE FEMALE LUER. THE REPORT DOCUMENTS THAT THE SEPARATION WAS DUCTILE WHERE THE MALE LUER AND THREAD SKIRT WERE BENT RATHER THAN BROKEN AND DID NOT EXHIBIT "BRITTLE" CHARACTERISTICS AS SEEN WITH THE RETURNED DEVICES. FINDINGS: ENGINEERING ANALYSIS OF THE "AS-RECEIVED" DEVICES CONFIRMED COMPONENT BREAKAGE OF A LUER LOCK SYRINGE MALE LUER INSIDE THE FEMALE LUER OF THE SPIROS CONNECTOR. THE ENGINEERING ANALYSIS OF THE COMPONENT BREAKAGE CHARACTERISTICS (BRITTLENESS) SUGGESTS THAT THE MATING SYRINGE MALE LUER WAS CHEMICALLY WEAKENED PRIOR TO THE BREAKAGE. THIS CONDITION COMBINED WITH UNINTENDED BENDING FORCES MOST LIKELY CONTRIBUTED TO THE BREAKAGE/DAMAGE AND RESULTANT LEAKAGE THAT OCCURRED. THE COMPLAINT INVESTIGATION REPORT, RELEVANT PHOTOGRAPHS WERE PROVIDED TO THE REPORTING FACILITY FOR THEIR REVIEW, UNDERSTANDING AND RECORDS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING A (B)(6) 2014 INCIDENT INVOLVING 20120-01 SPIROS CONNECTOR AND UNKNOWN SYRINGE. IT WAS REPORTED THAT THE "SPIROS SNAPPED OFF OF SYRINGE WHEN INFUSING DRUG INTO THE BAG..PHARMACY TECHNICIAN WAS SPRAYED WITH DRUG SCRUBS WERE CUT OFF AND THE TECHNICIAN WAS SENT DIRECTLY TO THE ED". THE TECHNICIAN WAS TREATED PER HOSPITAL PROTOCOLS AND DID NOT SUSTAIN ANY SERIOUS INJURIES OR ADVERSE OUTCOMES. DEVICE RETURN: ONE (1) USED 20120-01 SPIROS CONNECTOR, ONE (1) USED 30" 20 DROP ADMIN SET ATTACHED TO A 100ML HOSPIRA SALINE BAG; FOUR (4) USED 30ML BD SYRINGES; THREE (3) USED 20ML BD SYRINGES. VISUAL INSPECTION AND ANALYSIS (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE RESULTS RECORDED NO OBVIOUS ABNORMALITIES WITH THE RETURNED SYRINGES. THE VISUAL INSPECTION OF THE RETURNED USED SET UP RECORDED A MALE LUER FROM A LUER LOCK SYRINGE WAS BROKEN OFF INSIDE THE FEMALE LUER OF THE SPIROS THAT WAS CONNECTED TO THE ADMIN SET. DIMENSIONAL ANALYSIS PERFORMED ON THE SEVEN BD SYRINGES RECORDED THE MALE LUER TAPER MET THE ISO SPECIFICATIONS AND WERE COMPATIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305203 SPIROS CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20120-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI BD SYRINGE