MAUDE Adverse Event Report: CAREFUSION, INC ANES CIRCUIT, ADULT, 108 IN EXP, 1L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number G96LXXXA

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

The sample has been received by corporate headquarters to be decontaminated.Once the decontamination is completed on the product it will be sent to the quality engineers for analysis.Once the analysis is complete a supplemental report will be filed.(b)(4).

Event Description

It was reported by the customer that the doctors state that the elbow disconnects from the endotracheal tube during the middle of the case and during positioning.This issue occurred because the elbow was loosely fitting in the wye and gradually disconnected, leaving the elbow connected to the ett tube and the rest of the circuit is hanging separately.

Manufacturer Narrative

Follow up emdr submission, investigation results: correction to report date from initial emdr submission, the date on this follow up form of 05oct2016 is the alert date for report date for the initial submission.One incomplete circuit was received from the customer and was evaluated.During evaluation it was found that the elbow and the wye were found to be slightly out of specification.The reported issue of disconnect has been confirmed.Two years of complaints were reviewed from november 2014 to october 2016 and no trend was detected.The root cause of the confirmed issue is that manufacturing personnel failed to segregate the out of specification components during quality inspection.In addition, an opportunity for improvement was observed regarding how the components are inspected prior to being released for final assembly.Previously the components were manually inspected; however it was found that this could provoke a variation in the dimensional inspection.To correct this issue, manufacturing personnel have been retrained on proper assembly of the components.All material in inventory will be evaluated to confirm that the product is within specification to prevent disconnection of the circuit during use.The inspection method will be updated from a manual inspection to a mechanical inspection to eliminate any variation.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 1L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6037857
• MDR Text Key: 57773424
• Report Number: 8030673-2016-00250
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G96LXXXA
• Device Lot Number: 00000949582
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention