MAUDE Adverse Event Report: VYAIRE MEDICAL CONNECTOR OMNIFLEX 50/CS; CONNECTOR, AIRWAY (EXTENSION)

Model Number CONNECTOR OMNIFLEX 50/CS

Device Problem Connection Problem (2900)

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

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not returned for further evaluation.Based on the investigation since no pictures or physical sample were received we cannot confirmed the reported defect, we require the physical sample and/or pictures to perform a better investigation looking for the possible cause of the reported defect.In addition, the device history record of the fg 3222 was reviewed and no issues were found.Therefore, the root cause was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the isothermal adult omni connector doesn't fit securely on the trachea tube.Furthermore, the customer confirmed there was no harm done to the patient.

• Brand Name: CONNECTOR OMNIFLEX 50/CS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16705312
• MDR Text Key: 312946210
• Report Number: 8030673-2023-00310
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CONNECTOR OMNIFLEX 50/CS
• Device Catalogue Number: 3222
• Device Lot Number: 0004228483
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• 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: Unknown
• Patient Sequence Number: 1