MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ANESTHESIA BREATHING SINGLE LIMB CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number	C1038J
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the surgery, the breathing filter on the snake tube came off.There was no feeling of looseness, but with the current specification, the looseness occurs noticeably more often.The event occurred during use.There was no reported patient harm/adverse event.
Additional Manufacturer Narrative
B3: date of event is unknown.The primary di# has been used as the lot information is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
G1 - contact office region state: correction h3 and h6.Codes: updated.Device evaluation: received one (1) used product.One (1) customer video was returned with the customer rocking the breathing filter from two separate breathing circuits, showing that one is tightly fitted while the other is loosely fitted.No damage or anomalies observed on the returned product.To replicate clinical use, the blue filter was fitted onto the breathing circuit fully, and it was observed to fit snugly.A dimensional analysis was conducted on the breathing filter (male) and t connector end.The product measures within the listed specifications.The complaint of disconnection could not be confirmed nor replicated.A device history record review could not be performed as the lot number was unknown.

• Brand Name: PORTEX ANESTHESIA BREATHING SINGLE LIMB CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24571320
• Report Number: 3012307300-2026-02304
• Device Sequence Number: 15806958
• Product Code: CAI
• UDI-Device Identifier: 05019315059585
• UDI-Public: (01)05019315059585
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: Other
• Device Catalogue Number: C1038J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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