MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP HUDSON RCI ISO-GARD DRAIN BREATHING CIRCUIT (DUAL HEATED LIMB WITH DUAL DRAIN); ISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAIN

Catalog Number	HUD88015KIT
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per report, there were multiple failure events at (b)(6) hospital / pmc involving medline kit neonatal iso guard breathing circuit: hud88015kit, lot # 25doa334.
Additional Manufacturer Narrative
Per report, there were multiple failure events at (b)(6) hospital / pmc involving medline kit neonatal iso guard breathing circuit: hud88015kit, lot # 25doa334.

• Brand Name: HUDSON RCI ISO-GARD DRAIN BREATHING CIRCUIT (DUAL HEATED LIMB WITH DUAL DRAIN)
• Common Device Name: ISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAIN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25047545
• Report Number: 1417592-2026-00652
• Device Sequence Number: 18554864
• Product Code: OGG
• UDI-Device Identifier: 10197344010479
• UDI-Public: 10197344010479
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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
• Device Catalogue Number: HUD88015KIT
• Device Lot Number: 25DOA334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown