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

Model Number CATHETER 8FR CLOSED 50/CS

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 331196345
• Report Number: 3013421741-2023-00050
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 10190752140707
• UDI-Public: (01)10190752140707(10)20027533B
• Combination Product (y/n): N
• Reporter Country Code: HO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CATHETER 8FR CLOSED 50/CS
• Device Catalogue Number: CSC208
• Device Lot Number: 20027533B
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1