MAUDE Adverse Event Report: VYAIRE MEDICAL INC. CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD; CONNECTOR, AIRWAY (EXTENSION)

Model Number CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD

Device Problem Disconnection (1171)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that the 004081 connector u/adapit str 22mm id x 22mm od plug that closes the oxygen stem will not stay in place.This issue will lead to an unintentional circuit leak.There was no harm reported.

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.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: the quality personnel from molding area conducted a dimensional inspection of cap part number 65-1376d.This inspection revealed that all samples met the specified specifications.Furthermore, quality personnel from the incoming area conducted a dimensional inspection of connector part number 65-1481 on all physical samples and all samples were found to be within specifications.As a result, the reported defect was not confirmed.Based on the above, the reported defect was not confirmed and root cause not established.

• Brand Name: CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18332326
• MDR Text Key: 330577713
• Report Number: 8030673-2023-00364
• 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,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD
• Device Catalogue Number: 4081
• Device Lot Number: 0004260124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• 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: Initial
• Patient Sequence Number: 1