MAUDE Adverse Event Report: CAREFUSION SMARTSITE NEEDLE-FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2000E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hypoglycemia (1912); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that the smartsites are leaking.Product received was "d25", tpn, and lipids.

Manufacturer Narrative

Baby.Baby had blood sugar issues.

Event Description

It was reported that the needle free valves were leaking.The product received was labeled "d25", tpn, and lipids.Upon identification of the leak, the patient was experiencing a drop in blood sugar.The leaking product could not be ruled out as a cause of the hypoglycemia, although the patient had difficulty maintaining adequate blood sugar levels prior to the leaking event, as well as after the leaking event.The patient was believed to have received unspecified medical intervention for treatment of the low blood sugar.

Event Description

It was reported that the needle free valves were leaking.The product received was labeled "d25", tpn, and lipids.Upon identification of the leak, the patient was experiencing a drop in blood sugar.The leaking product could not be ruled out as a cause of the hypoglycemia, although the patient had difficulty maintaining adequate blood sugar levels prior to the leaking event, as well as after the leaking event.It was believed that the patient received unspecified medical intervention for treatment of the low blood sugar.

Manufacturer Narrative

The customer¿s report that the needle free valves were leaking was confirmed.No anomalies were noted on the smartsite or set upon initial visual inspection.Functional lab syringe iv push testing identified no leaks at each port or anywhere throughout the sets as they were received on the tifuse extension set.The set was back primed to test for leaks at the smartsite components.Leaks were observed at each of the (3) smartsite component s from the blue piston (b)(4).The root cause of the leak could not be determined.

• Brand Name: SMARTSITE NEEDLE-FREE VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8567235
• MDR Text Key: 143991295
• Report Number: 9616066-2019-01205
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: 7613203011938
• Combination Product (y/n): N
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2000E
• Device Catalogue Number: 2000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10839681, THERAPY DATE UNKNOWN
• Patient Outcome(s): Required Intervention