MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW LP NASAL PRONGS,MEDIUM

Catalog Number 777000M

Device Problem Infusion or Flow Problem (2964)

Patient Problem Anxiety (2328)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

Complaint title: brief description of event: the day of the event is (b)(6) 2019.The patient was treated in sipap.The nurse had been changing the prongs (ref.(b)(4)) to the mask when she noticed that there is a piece of silicone missing from the prongs.The reason for the changing was that cpap had been low for a while.After the switch the mask cpap had got better.The box of the prongs had been put to the trash when the prongs were applied to the patient.Patient condition before & after event: the baby was a bit anxious, but after the switch from the prongs to the mask the baby was calmer.

Manufacturer Narrative

Investigation results: based on the investigation and the sample sent by the customer, it was determined that the material is related with this issue since it was provided by an external supplier, that could have sent nonconforming material.Also manufacturing personnel did not follow the instructions indicated in our procedure which states how to perform the inspection for the device and thus could have avoided packing the defective component.Therefore, the root cause was determined as: material does not meet manufacturer's specifications.Personnel was retrained on that the holes in the prongs are not acceptable.In addition, scar 2019000053 was initiated to investigate this issue.

• Brand Name: INFANT FLOW LP NASAL PRONGS,MEDIUM
• Type of Device: NASAL PRONGS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9174932
• MDR Text Key: 168285681
• Report Number: 8030673-2019-00051
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 777000M
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1