MAUDE Adverse Event Report: CAREFUSION TEMNO EVOLUTION COAXIAL W/16G X 15CM NDL; KIT, NEEDLE, BIOPSY

Model Number CTT1615

Device Problems Accessory Incompatible (1004); Difficult To Position (1467); Fitting Problem (2183)

Patient Problem Internal Organ Perforation (1987)

Event Date 08/06/2014

Event Type  Injury  

Event Description

Account had an issue with the ctt line of needles when using the one size of the temno evolution.  due to the different sizes by only having one size introducer the "dead space" caused a physician to misjudge the distance causing a puncture of the lung.

Manufacturer Narrative

(b)(4).Follow-up report to be submitted upon completion of investigation.

• Brand Name: TEMNO EVOLUTION COAXIAL W/16G X 15CM NDL
• Type of Device: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 203 LTD; zona franca las americas; km 22 e-1; santo domingo ; DR
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4064798
• MDR Text Key: 17572227
• Report Number: 9680904-2014-00036
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CTT1615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other