MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; CIRCUIT, 90"EXP,1BV,3L

Catalog Number	DYNJAA9120
Medical Device Problem Codes	Crack (1135); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient became apneic due to ineffective ventilation and the patient "desat to 60s".Due to this, the anesthesia machine was abandoned and an ambu bag was used to ventilate the patient.It was reported that the patient recovered with intervention.A crack was found in the circuit causing lack of pressure and a new device was used.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Crack in circuit.
Additional Manufacturer Narrative
Updated g3, g6, h2, h6.

• Brand Name: MEDLINE
• Common Device Name: CIRCUIT, 90"EXP,1BV,3L
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23928043
• Report Number: 1417592-2025-00757
• Device Sequence Number: 9029826
• Product Code: CAH
• UDI-Device Identifier: 10080196827367
• UDI-Public: 10080196827367
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K925217
• 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,Followup
• Report Date (Section B): 01/06/2026

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?: Yes
• Device Catalogue Number: DYNJAA9120
• Device Lot Number: 25ABG823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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