MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE CLOSED SUCTION CATHETER¿NEONATAL 8 FR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	CATHETER 8FR 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
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.
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)(6) for the other incident involving csc110-catheter 10fr closed 50/cs.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.

• Brand Name: AIRLIFE CLOSED SUCTION CATHETER¿NEONATAL 8 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: 18360731
• Report Number: 3013421741-2023-00050
• Device Sequence Number: 8014748
• Product Code: BSY
• UDI-Device Identifier: 10190752140707
• UDI-Public: (01)10190752140707(10)20027533B
• 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 8FR CLOSED 50/CS
• Device Catalogue Number: CSC208
• Device Lot Number: 20027533B
• 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