MAUDE Adverse Event Report: VYAIRE MEDICAL, INC CONNECTOR U/ADAPIT STR 1 ARM NOBASE 50/C; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 004204-A

Device Problem Melted (1385)

Patient Problem Dyspnea (1816)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that ¿the oxygen port on this connector seems to have ¿melted¿ according to the facility, causing the oxygen concentrator unable to maintain liter flow¿.The patient did not change the adaptor in over one year.Once replaced with new adaptor, liter flow improved."the patient felt like she could not breathe and thought something was wrong with the concentrator when she noticed the ball to increase liter flow would not rise at all staying below 1 liter¿.The customer reported that the patient was not told to change the connector every 30 days.The customer reported that did not know this at the time, and now have seen this written on the package.The patient ¿did not have any respiratory comprise at all".

Manufacturer Narrative

Follow up submission: no sample was provided for evaluation.However, the customer confirmed that the device was in use longer than the specified time found on the labeling.A dhr review was completed and no issues were detected in the manufacturing that would contribute to this issue.2-yrs of complaints were reviewed and no trend was identified.The probably root cause is related to customer misuse.The customer did not change the adaptor in over a year when it is mentioned on the label that the adaptor should be used up to 30 days.This could cause the melted condition reported by the customer due to the fact that the plasticizers in the flexible pvc may damage the oxygen port.No corrective actions are indicated by the manufacturing facility.The customer has been made aware of the need to change the device up to 30 days according to the label.

• Brand Name: CONNECTOR U/ADAPIT STR 1 ARM NOBASE 50/C
• 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: 6624645
• MDR Text Key: 77212893
• Report Number: 8030673-2017-00341
• 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: consumer,distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004204-A
• Device Lot Number: 0000991207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• 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
• Patient Outcome(s): Required Intervention