MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number AIRLIFE¿ MODUDOSE¿ 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.If additional information becomes available.

Event Description

The customer reported that the airlife¿ modudose¿ 0.9% sodium chloride solution, usp 5 ml is molded together and will not break apart for single use.There are 4 singles molded together and must be cut apart with a box cutter to use.The customer confirmed that there was no harm associated with the reported event.

• Brand Name: AIRLIFE MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA; carretera san isidro mazatepec; 7000 tlajomulco de zúñiga; jalisco 45645
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11399874
• MDR Text Key: 244892400
• Report Number: 3007502289-2021-00001
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 20885403164849
• UDI-Public: (01)20885403164849(10)MPN80023553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AIRLIFE¿ MODUDOSE¿ 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML
• Device Catalogue Number: 5257
• Device Lot Number: MPN80023553
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: No
• 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