MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ADULT ANESTHESIA KIT-LF

Catalog Number	DYNJAA10832C
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the inside of the vent part is cracked.".
Additional Manufacturer Narrative
According to the customer, prior to use on a patient, it was discovered that the "inside part of the filter (that attaches to the mask) was broken", and the gas would not pump through; the customer reported there was no impact on the patient or procedure.A sample was received for investigation, the customer provided 1ea of component 126781 for sample evaluation, visual evaluation of the returned sample found a crack in the plastic of the inside ring of the vent, and finished good production records, finished good pack build, and trending were reviewed.Based on the complaint details, sample evaluation, and investigation, the complaint is confirmed.Based on the provided information and sample evaluation, the exact root cause for the reported issue cannot be determined; this complaint has been provided to the component manufacturing facility for further evaluation and the division 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: ADULT ANESTHESIA KIT-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869020
• Report Number: 1417592-2026-48793
• Device Sequence Number: 15797645
• Product Code: CAI
• UDI-Device Identifier: 10198459043819
• UDI-Public: 10198459043819
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/22/2026

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: DYNJAA10832C
• Device Lot Number: 25IBN284
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2025
• 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: 11/04/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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