MAUDE Adverse Event Report: VYAIRE MEDICAL FAST NEB W/TEE ADAPTER, 84" TUBING¿; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number FAST NEB W/TEE ADAPTER, 84" TUBING

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The customer stated no samples available for return.No photos taken of the leaking nebulizer, therapists disposed of them after the treatments.Multiple occurrences reported by various therapists of leaking medication from the nebulizer, lot numbers the same 0004119713.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the fast neb w/tee adapter, 84" tubing is leaking medication during patient use.The customer confirmed no harm occurred to the patient.

• Brand Name: FAST NEB W/TEE ADAPTER, 84" TUBING¿
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; 85 parque undustrial mex iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 7570116
• MDR Report Key: 9851226
• MDR Text Key: 201717550
• Report Number: 8030673-2020-00085
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10885403193255
• UDI-Public: (01)10885403193255(10)0004119713
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2020

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: FAST NEB W/TEE ADAPTER, 84" TUBING
• Device Catalogue Number: FN2438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1