MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI

Device Problem Contamination (1120)

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

Event Date 10/19/2023

Event Type  malfunction  

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 Description

The customer reported to vyaire medical that the tubing was very sticky and greasy to touch.The mask was used by a patient with no incidence observed during treatment.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation:the customer sent one opened physical sample for the investigation.The physical samples were visually inspected by quality personnel from assembly area according to pqas 001000 etal and it was observed that the product's tubing part number 58-1885 had a sticky feeling.Therefore, the defect reported by the customer was confirmed.Based on this information, we determined that environment may be related with the reported defect, since if the product is stored in a warm place the tubing may turned out sticky/greasy due to exude of plasticizer.The device history record of the fg part number 002433-a with lot number 0004133721 was reviewed and no issues were found.

Manufacturer Narrative

Result of investigation: based on the investigation since no pictures or physical sample were provided for the investigation, we cannot confirm the reported defect.We require the physical sample and/or pictures to perform a better investigation and determine the cause of the reported defect.Subsequently, based on the investigation and per physical samples received we can confirmed the reported defect since the sample was visually inspected and it was observed that it had a sticky feeling.Based on this information, we determined that environment may be related with the reported defect, since if the product is stored in a warm place the tubing may turned out sticky/greasy due to exude of plasticizer.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 18145402
• MDR Text Key: 328246056
• Report Number: 8030673-2023-00358
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752114821
• UDI-Public: (01)10190752114821(10)0004133721
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2023

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: AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI
• Device Catalogue Number: 2433
• Device Lot Number: 0004133721
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/24/2023; 11/24/2023
• Supplement Dates FDA Received: 11/27/2023; 11/28/2023
• 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