MAUDE Adverse Event Report: CAREFUSION GEN ANES SYS AFN529X5; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number GEWCWXAX

Device Problem Material Deformation (2976)

Patient Problem Perforation (2001)

Event Date 10/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Carefusion customer advocacy has made multiple attempts for additional information from the customer regarding patient involved in incident and any medical treatment that was needed regarding the situation.No information has been provided to carefusion to date regarding the request.No date no sample has been received for evaluation and a lot number has not been provided.If a sample becomes available, an evaluation will be completed.If any additional information become available a follow up emdr will be submitted.

Event Description

It was reported to carefusion by sales rep that item #gewcwxax; circuit, adult limb-o 72", 3l lf bag; sales consultant was visiting the sierra providence account on tuesday and one of the crnas told me about an incident that happened with our circuit configuration.Crna said that he was using our airway and yankauer and that the yankauer caused a preformation in the patent throat.He shared he thought it happened due to the 2 product not having the same curve.He said it happened 6 months ago and was unsure if it had been reported." pictures of patient's mouth and products involved were provided by customer, the customer's description of the pictures states " as you can see there is a perforation in this patent's soft palate and the other pic corresponds to how the contour of the yankauer does not follow the contour of the airway.

• Brand Name: GEN ANES SYS AFN529X5
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 1847362805
• MDR Report Key: 4782603
• MDR Text Key: 247200704
• Report Number: 2242551-2015-00027
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GEWCWXAX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other