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

Model Number	004081
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Correction: d4: corrected model, catalog and unique identifier(udi).D4 was updated to indicate correct model, catalog and udi #.

• Brand Name: CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD
• Common Device Name: 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: 18332349
• Report Number: 8030673-2023-00365
• Device Sequence Number: 8489682
• Product Code: BZA
• UDI-Device Identifier: 10190752154193
• UDI-Public: (01)10190752154193(10)0004259657
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2023

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: 004081
• Device Catalogue Number: 004081
• Device Lot Number: 0004259657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 07/15/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/04/2024; 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