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 Leak/Splash (1354)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

The spring loaded valves do not seal well, causing them to leak when a nebulizer is not attached.  mucomyst medication tends to be sticky and causes the valve to stick open when a nebulizer is removed, causing loss of ventilation volume.

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 three other reported complaints for a similar issue during this time period.The root causes of these could not be determined as the complaint product was not returned for evaluation.During this same time period carefusion has sold several million units, which does not indicate a negative trend.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): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3649673
• MDR Text Key: 4320388
• Report Number: 2050001-2014-00012
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 002061-A
• Device Lot Number: CM13L24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 02/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1