MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ANES CIRCUIT 90IN ADULT EXP-LF

Catalog Number	DYNJAA10312C
Medical Device Problem Codes	Mechanical Problem (1384); Material Twisted/Bent (2981); Failure to Seal (4070)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, the "we are seeing quite a few of the masks in the anesthesia kits that are bent at the connection of the tubing and the mask.This is not allowing for a seal when being used.".
Additional Manufacturer Narrative
According to the facility, the "we are seeing quite a few of the masks in the anesthesia kits that are bent at the connection of the tubing and the mask.This is not allowing for a seal when being used." no additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ANES CIRCUIT 90IN ADULT EXP-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23441813
• Report Number: 1417592-2025-00589
• Device Sequence Number: 4695403
• Product Code: CAI
• UDI-Device Identifier: 40193489274920
• UDI-Public: 40193489274920
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAA10312C
• Device Lot Number: 24HBD801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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