MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	CSC100
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - the customer mentioned thatt the unit/suspect device is not available for evaluation.Therefore, rootcause could not be determined.This report is for airlife¿ verso¿ airway access adapter.Please see (b)(4) for airlife closed suction catheter 14fr.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 available for evaluation.
Event or Problem Description
It was reported to vyaire medical that there was an stagnation of purulent secretions at the connector of csc100 adapter verso airway adult/ped 20/bx and csc114 catheter 14fr closed 50/c.There is no information on patient outcome.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 and h10.The dhr records has been thoroughly reviewed, and no abnormalities were detected during the inspection.The retained sample from the same production underwent testing under 80-200mmhg pressure, and its function is deemed acceptable.Upon reviewing the photos, it is observed that the secretions at the connector appear to be too thick.This thickness may lead to sticking on the valve of csc100, impacting the catheter's suction and potentially causing retention at the connector.
Additional Manufacturer Narrative
Correction: d4:corrected model and unique identifier(udi).D4 was updated to indicate correct model and udi #.

• Brand Name: AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PACIFIC HOSPITAL SUPPLY CO. LTD.; 4 f., no. 160, daye road; beitou district; taipei 366 ; TW 366
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18267955
• Report Number: 3013421741-2023-00047
• Device Sequence Number: 11738572
• Product Code: CAI
• UDI-Device Identifier: 10190752140561
• UDI-Public: (01)10190752140561(10)20028434
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2023

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: CSC100
• Device Catalogue Number: CSC100
• Device Lot Number: 20028434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 07/15/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/19/2024; 07/15/2024
• 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