MAUDE Adverse Event Report: CAREFUSION/BD ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number AGNX204X

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Carefusion has reached out to customer to provide the complaint device for further 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

Medwatch report (b)(4): the anesthesiologist had intubated the patient for a gynecological surgery, but was having difficulty ventilating the patient.Switched to "ambu bag" (resus bag) and ventilated without difficulty.The anesthesia breathing circuit was switched out and ventilation ensued with ease.Initial breathing circuit was inspected, and found to have a clear plastic covering over the intake valve of the filter.

Manufacturer Narrative

(b)(4).Unfortunately carefusion/bd did not obtain the affected sample or the requested additional information from the end-user; despite repeated attempts to do so.The device history record for the lot reported was evaluated for any issues related to the reported failure, and no issues were found.The product was manufactured, inspected and released in accordance with our internal procedures.Carefusion/bd is unable to determine a root cause for the reported failure on this product since the sample was not returned for evaluation.No corrective action will be implemented, since the defect could not be confirmed, but manufacturing personnel have been notified of this issue.

• Brand Name: ANES CIRCUIT, ADULT, 72 IN CORR, 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: 5814709
• MDR Text Key: 50235448
• Report Number: 8030673-2016-00184
• 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,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AGNX204X
• Device Lot Number: 0000872490
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 62