MAUDE Adverse Event Report: CAREFUSION ADAPTER VALVED TEE 22 MM OD/ID 30/CS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number 002061-A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/18/2013

Event Type  malfunction  

Event Description

The issue is that the spring in the valve is getting stuff or the plastic seat breaking and not letting the valve close.Per the customer: "it has been reported to me today that the new airlife tee adapter has failed on our respiratory patient.This is a critical failure due to the patient being on a vent.The issue is that the spring in the valve is getting stuff or the plastic seat breaking and not letting the valve close.The reorder number is 002061.These are part of the new respiratory contract.".Additional comments from customer:"good morning.Yesterday (b)(6) ordered a case of tee adapters manufactured by (b)(4).They arrived this morning and after comparing the two, i can say that there isn¿t a comparison.The hudson product has a much firmer spring and includes a rubber gasket for better sealing when not in use.(b)(6) explained to me this morning that the hudson product is 3.00 more per case, or 0.06 cents per unit.This is the item that i would like to continue ordering".Additional information received from the customer on (b)(6) 2014."good morning.The issue that i personally discovered occurred when an employee was troubleshooting a ventilator and the low volume and pressure alarms were alarming.When i proceeded to investigate the issue, a leak was detected from the valved t-adapter even with the cap secured appropriately.This leak was barely audible but did have an impact of ventilation.I replaced the adapter and the problem was solved.The ventilator in question was in use on a patient at that time but no noticeable adverse effects of this leak were observed.It was not until i asked a few other employees about these adapters that i discovered several of them had routinely changed these adapters for what appears to be a problem with them either closing completely after treatments or not sealing correctly.We unfortunately did not save any of these to return to you.".

Manufacturer Narrative

(b)(4).Sample was not available for evaluation.Upon carefusion's investigation, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4).The customer indicated that the complaint devices were not available for return to carefusion.As a result, an evaluation could not be performed.A review of the device history record (dhr) was performed for this lot by the manufacturing site.There were no issues identified with the manufacturing process of this lot that would have contributed to the reported issue.The product is 100% leak tested at the factory prior to final release.A review of the complaint system was performed for this product over the last four years.There have been no other reported complaints for this same issue during this time period.During this same time period carefusion has sold several million units.The reported issue will continue to be trended and monitored by carefusion.Without the actual complaint samples it is difficult to determine the exact root cause.The two most likely causes would be the strength of the spring (spring rate) and/or damage to the plastic seal.Either of these issues would have been identified during the 100% leak testing and would have been rejected.The spring rate of 30 random springs from inventory was tested and all were found to be within specification.Other possible causes would be damage in transit, misuse by the end user, or damage during handling.The exact root cause could not be determined without the returned complaint product.

• Brand Name: ADAPTER VALVED TEE 22 MM OD/ID 30/CS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3582314
• MDR Text Key: 4032671
• Report Number: 8030673-2014-00091
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 002061-A
• Device Lot Number: CM13E26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1