MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE CLOSED SUCTION CATHETER 10 FR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	CATHETER 10FR CLOSED 50/CS
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Please refer to (b)(4), for the other incident involving csc208-catheter 8fr closed 50/cs.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the csc110 catheter 10fr closed 50/cs and csc208 catheter 8fr closed 50/cs seems bend on the way through the et tube forcing the clinicians to disconnect the patient.There are no information on patient outcome.

• Brand Name: AIRLIFE CLOSED SUCTION CATHETER 10 FR
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PACIFIC HOSPITAL SUPPLY CO. LTD.; 4f, 160 daye rd. beitou distri; ct (owner operator address) no; taipei ; TW
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18360628
• Report Number: 3013421741-2023-00049
• Device Sequence Number: 7731154
• Product Code: BSY
• UDI-Device Identifier: 10190752140578
• UDI-Public: (01)10190752140578(10)20007149C
• Combination Product (Y/N): N
• Initial Reporter Country: HO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: CATHETER 10FR CLOSED 50/CS
• Device Catalogue Number: CSC110
• Device Lot Number: 20007149C
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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