MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ANESTHESIA CIRC PEDIATRIC-LF

Catalog Number	DYNJAP9799G
Medical Device Problem Codes	Material Perforation (2205); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the circuit failed the leak test.Additionally, there were observations of jagged edges and a connection issue.
Additional Manufacturer Narrative
It was reported that the circuit failed the leak test.Additionally, there were observations of jagged edges and a connection issue.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 reportable event was previously submitted under mdr number 1423395-2026-00265.Following evaluation of the returned sample, it was determined that the event had been submitted under an incorrect manufacturer account.Therefore, the event is being resubmitted under the correct mdr number.

• Brand Name: MEDLINE
• Common Device Name: ANESTHESIA CIRC PEDIATRIC-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25600009
• Report Number: 1417592-2026-03055
• Device Sequence Number: 9972037
• Product Code: CAI
• UDI-Device Identifier: 10195327461287
• UDI-Public: 10195327461287
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 06/23/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAP9799G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/23/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown