MAUDE Adverse Event Report: CAREFUSION SMALLBORE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number 20129E

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem Hypoglycemia (1912)

Event Date 09/10/2016

Event Type  Injury  

Manufacturer Narrative

A picture was provided by the customer showing a female luer connected to a male luer with a white solution that is similar in appearance to lipids.However, no leaks were observed on the connections.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that a leak occurred twice in succession on the same patient, at the threads of the connection between two extension sets.The tubing had been changed on (b)(6) 2016 at 2118 and the blood glucose was reported to be within normal limits before and after.At 2300, the filter on the lipid infusion was noted to be leaking.The connection was cleaned and tightened but found to be leaking again on (b)(6) 2016 at 0146.The patient's blood glucose was 44; the tubing was changed and no further intervention was provided.At 0323 the blood glucose was rechecked and the level was 120.No lasting harm to the patient was reported.

Manufacturer Narrative

Additional information received from customer's medwatch.

Event Description

Received a copy of the customer¿s medwatch report which states ¿event desc: leaking at connection with microbore tubing.¿.

Manufacturer Narrative

(b)(4).Syringe.

• Brand Name: SMALLBORE EXTENSION SET
• Type of Device: SET, EXTENSION, 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: 6024664
• MDR Text Key: 57247135
• Report Number: 9616066-2016-01387
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20129E
• Device Catalogue Number: 20129E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 20129E, THERAPY DATE
• Patient Outcome(s): Other
• Patient Age: 12 DA
• Patient Weight: 1