MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE PEDIATRIC OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, MEDIUM CONCENTRATION; CANNULA, NASAL, OXYGEN

Model Number	MASK OXYGEN UNDERCHIN PED 50/CS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that prior to placing 001262 - mask oxygen underchin ped 50/cs on the patient, staff identified a bug with some debris in the tubing.The customer confirmed that the event occurred pre-operatively, and no patient was involved.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.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 returned yet.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 and h10 based on the investigation carried out and per picture and physical sample received, reported defect is confirmed (bug inside the tube).However, proper pest controls were established indicating a monthly fumigation of external and internal installation of vyaire's plant.Fumigation certificates from nov 2019 and dec 2019 were reviewed, and no anomalies were found during that period of time.The device history record was reviewed, and no issues were found.Therefore, the root cause was undetermined.

• Brand Name: AIRLIFE PEDIATRIC OXYGEN MASK VINYL, UNDER-THE-CHIN STYLE, MEDIUM CONCENTRATION
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd me; mettawa IL 60045
• 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 ; 2402760001
• MDR Report Key: 16921956
• Report Number: 8030673-2023-00319
• Device Sequence Number: 7032982
• Product Code: CAT
• UDI-Device Identifier: 10190752116542
• UDI-Public: (01)10190752116542(10)0004123269
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2024
• Device Model Number: MASK OXYGEN UNDERCHIN PED 50/CS
• Device Catalogue Number: 001262
• Device Lot Number: 0004123269
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 05/24/2023
• 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