MAUDE Adverse Event Report: CAREFUSION/BD B1514XXX; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number B1514XXX

Device Problem Disconnection (1171)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

It has been confirmed 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 situation reported with the device.Customer advocacy is still waiting for additional information regarding the reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

Customer reported that ¿drs.(b)(6) (chief) were in this reported case.A lot of times the connections to the machine are blocked by a drape, and they are not always visible to the anesthesia staff.They said he had already been a difficult airway; this issue risked further airway issues, and spasms which would have caused major issues.The child moved his head and they saw him start to wake up.They reported it as a ¿stage 2¿.The circuits¿ limb fell out/disconnected from the anesthesia machine.The limb landed on the floor.They caught it just in time to keep things from getting fully out of control.On top of the patient waking up, there is great concern of anesthesia gases being delivered to the anesthesia staff, and out into the room¿.The reported item was being used on a patient.There was no patient harm or medical intervention required¿.

Manufacturer Narrative

Follow up submission: three samples were received for evaluation and the reported issue of disconnection could not be confirmed.The device history records for the lot numbers reported and received were evaluated, and no issues were observed related to this report.Two years of complaints were reviewed and no adverse trend was identified.Even though the reported issue could not be confirmed with the samples received, the manufacturing and quality processes were reviewed and were found with acceptable specifications for producing the product.An area of improvement was observed with how the inspection method was being performed.To improve our process, the manual inspection process was change to a mechanical inspection to avoid gauge insertion error when dimensionally inspecting components.We will continue to monitor and trend for this issue.

• Brand Name: B1514XXX
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6166030
• MDR Text Key: 62118042
• Report Number: 8030673-2016-00268
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B1514XXX
• Device Lot Number: 0000981007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• 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