MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 72 IN CORR, 2L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AFNXMXXC

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 11/23/2016

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.If any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported a hole in the septum of the limbo; it was visually estimated to be about 5 mm in diameter.The customer reported that the ¿limbo still passed the leakage test¿.It was confirmed that there was no patient or user impact or harm.The customer disposed of the circuit the device will not be available for investigation.

Manufacturer Narrative

Follow up emdr submission: the complaint sample was discarded by the end user and was unavailable for evaluation.However, the device history record for the lot number reported was reviewed and no issues were observed.The product was manufactured, inspected and released in accordance with our internal procedures.A 2-year retrospective review of complaints was performed and no adverse trend was detected related to this issue.The current product line is running according to procedure and this product is 100% visually and functionally inspected prior to the final packaging stage.Based on the investigation, at this time it is not possible to determine a root cause for the issue reported on the product since the sample was not available for evaluation.

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR, 2L BAG
• 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: 6190816
• MDR Text Key: 62912846
• Report Number: 8030673-2016-00271
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AFNXMXXC
• Device Lot Number: 0000904300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• 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