MAUDE Adverse Event Report: CAREFUSION SMARTSITE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 20127E

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of air below the tubing filter was confirmed.Visual inspection revealed a crack in the female luer wall.No tool marks or signs of over torque were observed.Functional testing resulted in a leak at the crack.The cause of air getting into the line is a crack on the female luer located above the filter component.The root cause of this failure was not determined.

Event Description

The customer reported that tpn was programmed to infuse at 24ml/hr; air was noted below the tubing filter while connected to the patient's picc line.There was no report of a breakage or leakage from the sets and there was no patient harm.

• Brand Name: SMARTSITE EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6537355
• MDR Text Key: 74199584
• Report Number: 9616066-2017-00700
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20127E
• Device Catalogue Number: 20127E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2000E,2426-0007,8015,8100,PICC