BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAGON ADMINISTRATION SET

    MDR report key: 3181690 · Received June 14, 2013

    Report

    Report Number
    2026095-2013-00107
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    FRN
    PMA / PMN Number
    K020251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL OF THE SAMPLE DEVICE WAS PERFORMED BY (B)(6), THE FOLLOWING INVESTIGATION AND ANALYSIS WAS RETAINED FROM (B)(6) FOR FILING PURPOSES. METHOD: REC'D ONE EMPTY PARAGON ADMINISTRATION SET FOR EVAL AND INVESTIGATION. A VISUAL INSPECTION REVEALED WHITE PARTICULATE INSIDE THE RESERVOIR. A PRESSURE POT TEST WAS PERFORMED. RESULTS: DURING THE PRESSURE TEST, A 10 ML SYRINGE WAS FILLED WITH SALINE. DURING PRESSURIZED INJECTION THROUGH THE INJECTION PORT, A LEAKAGE WAS CONFIRMED, OCCURRING AT THE VENT MEMBRANE. HOWEVER, NO DETERMINATION COULD BE MADE AS THE CAUSE OF THE LEAKAGE. A REVIEW OF DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE MET MFG AND QUALITY SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: THE (B)(4); NO CORRECTION ACTION IS REQUIRED AT THIS TIME. THE INCIDENT HAS BEEN INCLUDED IN THE DATABASE AND WILL BE MONITORED.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5FU IN NS, FILL VOLUME: 84 ML, FLOW RATE: 0.5 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: INTRAVENOUS (THIS IS A COMPLAINT THAT I-FLOW REC'D FROM OUR BUSINESS PARTNER (B)(6)). THE CUSTOMER STARTED TO USE THE SUBJECT DEVICE ON (B)(6) 2013 FOR CONTINUOUS DRUG INFUSION. THE CHEMOTHERAPY DRUG CONTAINED FLUORINE. ON THE EVENING OF (B)(6) 2013, THE CUSTOMER FOUND A SPILLAGE OF CHEMOTHERAPY DRUG FROM THE FILTER OF THE SUBJECT DEVICE CAUSING CONTAMINATION OF THE PT. THE LEAKAGE OF LIQUID CAUSED THE CONTACT OF CYTOTOXIC DRUG WITH THE PT. THERE WAS NO REPORTED ADVERSE EVENT TO THE PT. ALSO, THERE WAS NO INJURY, ILLNESS OR MEDICAL INTERVENTION. THE SAMPLE WAS EVALUATED BY (B)(6). IT WILL NOT BE RETURNED TO I-FLOW FOR FURTHER EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271195 PARAGON ADMINISTRATION SET ELASTOMERIC PUMP FRN I-FLOW, LLC PG100005 112113

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR