MAUDE Adverse Event Report: ICU MEDICAL BCI ADAPTER AIRWAY FILTERLESS; ANALYZER, GAS, CARBON-DIOXIDE

Catalog Number	WW1100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the airway adapter of the device broke in half which is known as a recall.There was no patient harm reported as a result of the event.There was also no medical intervention.However, the care team needed to keep adjusting airway adapter.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
A1 - patient identifier: updated.H3 and h6 codes: updated.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BCI ADAPTER AIRWAY FILTERLESS
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE
• Manufacturer (Section D): ICU MEDICAL; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21777213
• Report Number: 3012307300-2025-03789
• Device Sequence Number: 12969150
• Product Code: CCK
• UDI-Device Identifier: 35019517062667
• UDI-Public: (01)35019517062667(17)331210(10)4446699
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K030407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: Health Professional
• Device Catalogue Number: WW1100
• Device Lot Number: 4446699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1404-2025
• Patient Sequence Number: 1
• Patient Age: 17 MO
• Patient Sex: Unknown
• Patient Weight: 3 KG