MAUDE Adverse Event Report: WALKMED TECHNOLOGIES, LLC WALKMED® 150 ML RESERVOIR BAG; INFUSION PUMP ACCESSORY, RESERVOIR BAG

Model Number	IPR-150
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: WALKMED® 150 ML RESERVOIR BAG
• Common Device Name: INFUSION PUMP ACCESSORY, RESERVOIR BAG
• Manufacturer (Section D): WALKMED TECHNOLOGIES, LLC; 1390 s. potomac suite 110.; aurora CO 80012
• Manufacturer (Section G): WALKMED TECHNOLOGIES, LLC; 1390 s. potomac st; suite 110; aurora CO 80012
• Manufacturer Contact: trinidad baca ; 1390 s. potomac st; suite 110; denver, CO 80012
• MDR Report Key: 22986876
• Report Number: 3000204189-2025-00002
• Device Sequence Number: 13004884
• Product Code: FRN
• UDI-Device Identifier: 00859695006053
• UDI-Public: 00859695006053
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K870524
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPR-150
• Device Catalogue Number: 204821
• Device Lot Number: 20724509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A (NO CORRECTION/REMOV
• Patient Sequence Number: 1
• Patient Sex: Unknown