MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE NEBULIZER STERILE WATER INHALATION KIT PREFILLED, 1000ML; HUMIDIFIER NEBULIZER KIT

Model Number NEB KIT W ADAPTER STERILE WATER 1000ML

Device Problem Leak/Splash (1354)

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

Event Date 07/14/2023

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.H3 other text : device not returned yet.

Event Description

It was reported that the vyaire medical that the neb kit w adapter sterile water 1000ml is attached to oxygen flow and placed on a patient, the water would leak out of the entrainment port all over the floor.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: based on the investigation and per physical samples received, we cannot confirm the reported defect since the sample was functionally inspected per pqas ck0005 etal performing a vacuum test as well as gage rings diameter verification and no issues were found.Additionally, the device history records of the fg kit prefill neb w neb cap sterile water part number ck0010 with lot number 0004250078 was reviewed and no issues were found.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE NEBULIZER STERILE WATER INHALATION KIT PREFILLED, 1000ML
• Type of Device: HUMIDIFIER NEBULIZER KIT
• 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; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17538074
• MDR Text Key: 321038009
• Report Number: 8030673-2023-00347
• Device Sequence Number: 1
• Product Code: OGG
• UDI-Device Identifier: 10190752158450
• UDI-Public: (01)10190752158450(10)0004250078
• 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: 08/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEB KIT W ADAPTER STERILE WATER 1000ML
• Device Catalogue Number: CK0010
• Device Lot Number: 0004250078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• 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