MAUDE Adverse Event Report: CAREFUSION SMARTSITE EXTENSION SET; FILTER, INFUSION LINE

Model Number 20027E

Device Problems Backflow (1064); Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 02/18/2016

Event Type  malfunction  

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

The customer reported that a crack in the tubing caused the fluid to leak and blood backed up into the tubing in the nicu.Per the customer contact, there are no further details of this event, and no patient harm was reported.

Manufacturer Narrative

The customer¿s report of cracked and leaking extension tubing was confirmed.Functional testing was performed; fluid was observed leaking from the side of the luer.Microscopic examination revealed crazing at the leak site and a short, thin crack on the side of the lower portion of the female luer.The root cause of the crack was not identified.

• Brand Name: SMARTSITE EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• 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: 5510340
• MDR Text Key: 40664803
• Report Number: 9616066-2016-00384
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• 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: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20027E
• Device Catalogue Number: 20027E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• 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