MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 72 IN CORR; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AFNXXXXX

Device Problem Disconnection (1171)

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

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

Sample is available, ups shipping labels provided to customer to have the sample returned.Currently awaiting for the sample.Once the investigation is complete a follow up submission will be filed.

Event Description

Customer reported that "the limb adapter tip does not hold enough (not tight enough) on the aysis anesthesia connection.Several disconnections occurred during the procedure".No allegation of patient harm.No erroneous results or medical intervention required due to issue described.

Manufacturer Narrative

Unfortunately the sample was not received for further evaluation into the reported issue.No further investigation can be provided.The device history record (dhr) was reviewed for the reported lot numbers.These lots were manufactured and released per our internal procedures and no issues were found.The manufacturing procedure and quality inspection procedures were evaluated and no issues were found without the sample to confirm the reported issue and find a root cause.Vyaire has determined no corrective or preventative actions will be required at this time.

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n riverwoods blvd; mettawa IL 60045
• MDR Report Key: 7156613
• MDR Text Key: 96134090
• Report Number: 8030673-2018-00396
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AFNXXXXX
• Device Lot Number: 0001161276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention