MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 90 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number A5Z51914

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed that the sample has been received in (b)(4) at the holding center.As soon as the affected sample is released by (b)(6) customs to the manufacturing facility in (b)(4) the sample evaluation will be performed.A follow up mdr will be sent once the investigation has been completed.

Event Description

Customer reported "the breathing bag will disconnect from the bag arm of the anesthesia machine typically during a ¿bagging¿ part of the case.The disconnect is occurring while the patient circuit and bag are under pressure and being pulled at a slight angle".

Manufacturer Narrative

Device evaluation: one sample was provided for dimensional inspection and all components were found within specification except the elbow.The elbow was found to be.006 below specification; however it did pass the iso gauge test and it would be assembled without disconnection.Based on the investigation the reported disconnection could have been caused during shipping transportation.The information for use instructs the anesthesia team to ensure that all connections are tight and have not loosened during transit.This information has been sent to the customer providing follow up education.

• Brand Name: ANES CIRCUIT, ADULT, 90 IN EXP, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• 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: 6888869
• MDR Text Key: 87173359
• Report Number: 8030673-2017-00370
• Device Sequence Number: 1
• Product Code: CAI
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A5Z51914
• Device Lot Number: 0001117390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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