BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    WALKMED® 150 ML RESERVOIR BAG

    MDR report key: 22986876 · Received September 5, 2025

    Report

    Report Number
    3000204189-2025-00002
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 26, 2025
    Manufacturer
    WALKMED TECHNOLOGIES, LLC
    Product Code
    FRN
    UDI-DI
    00859695006053
    PMA / PMN Number
    K870524
    Removal / Correction Number
    N/A (NO CORRECTION/REMOV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINGLE-USE RESERVOIR BAG OBSERVED WITH VISIBLE PARTICULATES DURING SETUP PRIOR TO INFUSION; NO PATIENT EXPOSURE, INJURY, OR THERAPY DELAY REPORTED. DEVICE DETAILS: CAT. 204821, MODEL IPR-150/10 (150 ML), LOT 20724509, UDI (B)(4), 510(K) K870524, FDA DEVICE LISTING D044578. THE UNIT WAS RETURNED UNDER RGA #2025-0098 AND IS AVAILABLE FOR EVALUATION. INITIAL REPORT CODING: A2969 (DEVICE CONTAMINATED DURING MANUFACTURE/SHIPPING), B10 (TESTING OF ACTUAL/SUSPECTED DEVICE), C3233 (RESULTS PENDING), D11 (CONCLUSION NOT YET AVAILABLE), E4582 (NO CLINICAL SIGNS/SYMPTOMS), F2199 (NO HEALTH CONSEQUENCES/IMPACT). FOLLOW-UP INFORMATION HAS BEEN REQUESTED FROM THE FACILITY PER SOP GOOD-FAITH ATTEMPTS; A FOLLOW-UP MDR WILL BE FILED IF NEW INFORMATION OR CONCLUSIONS BECOME AVAILABLE.

    Description of Event or Problem · 0

    A SEALED 150 ML INFUSION BAG (WALKMED ACCESSORY) WAS FOUND TO CONTAIN VISIBLE PARTICULATE MATTER PRIOR TO PATIENT USE. THE BAG WAS QUARANTINED; NO PATIENT EXPOSURE AND NO HARM WERE REPORTED. INVESTIGATION IS OPEN; EXTERNAL LABORATORY IDENTIFICATION/COUNT OF PARTICULATES IS PENDING. LOT HISTORY, COA, AND INCOMING INSPECTION RECORDS ARE UNDER REVIEW. THIS INITIAL MDR IS SUBMITTED AS A MALFUNCTION DUE TO THE POTENTIAL FOR SERIOUS INJURY IF UNDETECTED PARTICULATE WERE INFUSED. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL SIGNIFICANT INFORMATION. INITIAL REPORT SUBMITTED AFTER 30 DAYS DUE TO ESUBMITTER/ADOBE/CERTIFICATE ISSUES, NOW RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320707 WALKMED® 150 ML RESERVOIR BAG INFUSION PUMP ACCESSORY, RESERVOIR BAG FRN WALKMED TECHNOLOGIES, LLC IPR-150 20724509 00859695006053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown