MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number A4UX2044

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Customer advocacy has reached out to customer to provide sample for the investigation.Ups label was provided to the customer.At this time we are currently waiting for the sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.(b)(4).

Event Description

The customer reported that the attached 5708 hepa filter is separating when connected to a mask.The filter is breaking apart.It was confirmed that there was patient involvement with no harm.

Manufacturer Narrative

Device evaluation summary: complete circuits were received for evaluation a visual inspection was performed and no issues related to this customers report were found.Therefore the failure mode reported was not confirmed with the provided samples.The device history records were reviewed and no issues related to the reported failure mode were observed.Based on similar complaints it is considered that the manufacturing equipment could be related to this type of failure.Carefusion/bd found that the ultra sonic welding equipment was not stopping the next welding cycle from starting if an alarm was generated for a failure.Carefusion/bd has found that this equipment has opportunity for improvement.A corrective and preventative action plan has been opened to further investigate the reported unconfirmed failure.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 3L 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 ; 7149227830
• MDR Report Key: 5990772
• MDR Text Key: 56049280
• Report Number: 8030673-2016-00238
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A4UX2044
• Device Lot Number: 0000947710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• 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): Other