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

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.

Event Description

The customer reported to vyaire medical that the connector omniflex 50/cs doesn't fit securely on the tracheal tube.The said issue occurred during patient use.Furthermore, there was no harm done to the patient.

Manufacturer Narrative

Result of investigation: based on the investigation and per sample received after it was functionally inspected by quality personnel from assembly area according to pqas 3215 etal, 15mm plug test was performed and 16 units of 150 failed the test, for that reason the reported defect was confirmed.We consider that manufacturing personnel may be related to the reported defect, due to an incorrect disposition of the rejected units.Process states that units that pass the test can continue through the process and those that fail must be rejected, manufacturing personnel must properly place the rejected and accepted units in the respective container, if this stage of the process is not properly follow, a defect such as the one reported on this complaint could occur.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CONNECTOR OMNIFLEX 50/CS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16154855
• MDR Text Key: 307299702
• Report Number: 8030673-2023-00291
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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
• Device Operator: Health Professional
• Device Model Number: CONNECTOR OMNIFLEX 50/CS
• Device Catalogue Number: 3222
• Device Lot Number: 0004230645
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 04/05/2023
• 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: Unknown
• Patient Sequence Number: 1