MAUDE Adverse Event Report: Medline Industries, Inc.; ANESTHESIA CIRCUIT EXP-LF

Model Number	DYNJAA10640
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the anesthesia circuit disconnected during patient use.When this occurred, the clinician user indicated that the originally planned method of anesthesia induction was changed to a different one.The clinician end-user indicated that there was no adverse patient impact related to the incident.No sample was returned to the manufacturer for evaluation.A root cause was unable to be determined at this time.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the anesthesia circuit disconnected during patient use.

• Brand Name: Medline Industries, Inc.
• Common Device Name: ANESTHESIA CIRCUIT EXP-LF
• MDR Report Key: 12474859
• Report Number: 1417592-2021-00174
• Device Sequence Number: 11709331
• Product Code: CAI
• UDI-Device Identifier: 10889942801275
• UDI-Public: 10889942801275
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: DYNJAA10640
• Device Catalogue Number: DYNJAA10640
• Device Lot Number: 21FBK886
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention