MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HME,FILTER,ADLT,COMPACT,STRAIGHT,W/PORT

Catalog Number	DYNJAAHME9
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "stanford health has identified a cracked (b)(6) in their custom anesthesia circuit kit, item (b)(6)" and "they found the fhme cracked inside the packaging.".
Additional Manufacturer Narrative
The customer stated that they found the fhme cracked inside the packaging.Medline quality received one unit and visually inspected the sample with no original packaging.The damaged of the cracked filter was confirmed.Based on the complaint details and sample, the issue most likely occurred due to an outside source at some point during production, transit, usage, or storage; the quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: HME,FILTER,ADLT,COMPACT,STRAIGHT,W/PORT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50818743
• Report Number: 1417592-2026-44657
• Device Sequence Number: 10680842
• Product Code: BYD
• UDI-Device Identifier: 10884389120484
• UDI-Public: 10884389120484
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: DYNJAAHME9
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown