BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPR150 150 ML RESERVOIR BAG, F-LUER

    MDR report key: 12786991 · Received November 9, 2021

    Report

    Report Number
    MW5105227
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Report Date
    November 5, 2021
    Manufacturer
    WALKMED, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNIDENTIFIED PARTICLES OBSERVED IN 150 ML RESERVOIR BAGS (REF#: 204821) FOR THE WALKMED 350 VL PUMP SUPPLIED BY INFUSYSTEM (B)(6). ON (B)(6) 2021 WE NOTICED PARTICLES IN 4 BAGS AFTER DRUG HAD BEEN ADDED, AND NOTICED PARTICLES IN AT LEAST 2 BAGS FRESH OUT OF PACKAGING, BEFORE ANYTHING HAD BEEN ADDED, SO WE ARE CONFIDENT THAT THE PARTICLES ARE ORIGINATING FROM THE BAGS. WE RETURNED THESE TWO BAGS TO INFUSYSTEM ON 11/3/21 AND INFORMED THEM OF OUR ISSUE, AND ARE WAITING FOR THEIR RESPONSE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677582 IPR150 150 ML RESERVOIR BAG, F-LUER PUMP, INFUSION FRN WALKMED, LLC
    1677583 IPR150 150 ML RESERVOIR BAG, F-LUER PUMP, INFUSION FRN WALKMED, LLC
    1677584 IPR150 150 ML RESERVOIR BAG, F-LUER PUMP, INFUSION FRN WALKMED, LLC
    1677585 IPR150 150 ML RESERVOIR BAG, F-LUER PUMP, INFUSION FRN WALKMED, LLC
    1677586 IPR150 150 ML RESERVOIR BAG, F-LUER PUMP, INFUSION FRN WALKMED, LLC
    1677587 IPR150 150 ML RESERVOIR BAG, F-LUER PUMP, INFUSION FRN WALKMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown