BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROS, SPINNING CONNECTOR

    MDR report key: 4436006 · Received January 2, 2015

    Report

    Report Number
    2025816-2014-00150
    Event Type
    Malfunction
    Date Received
    January 2, 2015
    Date of Event
    November 5, 2014
    Report Date
    November 7, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING TESTING AND ANALYSIS: VISUAL ANALYSIS (PRE AND POST DECONTAMINATION) RECORDED NO OBVIOUS ABNORMALITIES. DURING DECONTAMINATION FLUSHING THERE WERE NO LEAKAGES OBSERVED. ENGINEERING TESTING AND EVALUATIONS OF BOTH THE SPINNING SPIROS CONNECTOR AND MONOJECT SYRINGE WAS PERFORMED. THE RESULTS RECORDED NO LEAKAGE ISSUES AND OR PERFORMANCE ABNORMALITIES WERE REPLICATED. MFG LOT BUILD RECORD REVIEW FOR THE "POTENTIAL" MFG LOTS WAS PERFORMED. THE RESULTS RECORDED ALL OF THE IDENTIFIED MFG LOT BUILD DATABASE RECORD ANALYSIS SHOWS THE 20130-01 CONNECTOR DEVICES WERE MANUFACTURED TO SPEC, TESTED, INSPECTED AND RELEASED. THE RECORD ANALYSIS DOCUMENTED NO FINDINGS THAT IDENTIFY THAT THE DEVICES WERE DEFECTIVE, NON-CONFORMING. FINDINGS: ENGINEERING TESTING AND EVAL OF THE RETURNED 20130-01 SPINNING SPIROS CONNECTOR DEVICE DID NOT REPLICATE THE REPORTED ISSUE AND OR CONFIRM ANY PERFORMANCE OF MFG NON-CONFORMANCES. THERE WAS NO LEAKAGE IN EITHER THE ACTIVATED OF UNACTIVATED CONDITIONS WHEN CONNECTED TO THE 35ML MONOJECT SYRINGE. THE EXACT CAUSE(S) OF THE REPORTED EVENT ARE UNK. THE USER FACILITY PROVIDED PG 1 COPY OF THEIR FORM FDA 3500 (10/05).

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING LEAKAGE INCIDENT WHERE SET-UP/DEVICES IN USE INCLUDED 20130-01 SPINNING SPIROS CONNECTOR. IT WAS REPORTED "DURING IV PUSH ADMINISTRATION OF ADRIAMYCIN, MEDICATION LEAKED FROM THE SPIROS AND DROPLETS SPRAYED ON THE ADMINISTRATING NURSE'S CHECKS AND NECK. A PINPOINT DROP WAS NOTICED ON THE PT'S RIGHT ELBOW. DECONTAMINATION OF THE PT AND NURSE OCCURRED. THE NURSE WAS SEEN IN THE ED PER EMPLOYEE HEALTH PROTOCOLS AND POISON CONTROL WAS NOTIFIED WHO ADVISED NO FURTHER TREATMENT OTHER THAN DECONTAMINATION PROCESSES ALREADY DONE WERE NEEDED. (MEDICATION ABSORBED WITH DRY GAUZE, CLOTHING REMOVED, SOAP AND WATER SCRUB THEN WATER FLUSH X 15 MINUTES). THE NURSE EXPERIENCED MINOR SKIN IRRITATION. THE PT EXPERIENCED NO ADVERSE EFFECTS.... THE CONNECTOR WAS INITIALLY PLACED APPROX ONE HOUR PRIOR TO THE IV PUSH ADMINISTRATION. THE INITIAL SET UP WAS DONE UNDER THE HOOD IN PHARMACY AND NO INITIAL PROBLEMS WERE ENCOUNTERED IN THE SET UP OR PRIMING." DEVICE RETURN: ONE USED 20130-01 SPINNING SPIROS ATTACHED/MATED TO 35ML MONOJECT SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874 SPIROS, SPINNING CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 20130-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR 35ML MONOJECT SYRINGE, NO OTHER INFO