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

Model Number ADAPTER VERSO ADULT/PED 45 DBL SWVL ELBO

Device Problem Contamination (1120)

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

Event Date 11/13/2023

Event Type  malfunction  

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 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.

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.

• Brand Name: AIRLIFE¿ VERSO¿ AIRWAY ACCESS ADAPTER
• Type of Device: 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
• MDR Text Key: 329738799
• Report Number: 3013421741-2023-00047
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADAPTER VERSO ADULT/PED 45 DBL SWVL ELBO
• Device Catalogue Number: CSC100
• Device Lot Number: 20028434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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