MAUDE Adverse Event Report: VYAIRE MEDICAL, INC TEE VALVED W/STEM AND PORT 15MM ID BASE; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 004050-A

Device Problem Material Fragmentation (1261)

Patient Problem Hypoventilation (1916)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by (b)(4) that the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device.If a sample or any additional information becomes available a follow up emdr will be submitted.

Event Description

Customer reported that the part broke apart during patient use and a part lodged in the circuit causing the patient to have to be unhooked from the ventilator and put on a resuscitation bag.Customer does not have the broken part or the lot information.There was no physical damage caused to the circuit.The circuit was new on (b)(6) 2017 at 0315.When in the part lodged into the circuit the patient had high peak airway pressures and low volume.Rt and rn both bedside immediate response to bag the patient.

• Brand Name: TEE VALVED W/STEM AND PORT 15MM ID BASE
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045
• MDR Report Key: 6965081
• MDR Text Key: 89832982
• Report Number: 8030673-2017-00372
• Device Sequence Number: 1
• Product Code: BZA
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004050-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• 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