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

Model Number 2000E7D

Device Problem Flushing Problem (1252)

Patient Problem Respiratory Distress (2045)

Event Type  Injury  

Manufacturer Narrative

The model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is indicated in model#/catalog #: "other#".The 510k number provided in the report is for the domestic similar product.No product return was required for this investigation as the customer feedback did not indicate a product defect.The feedback received states that the user did not flush the line post administration of anesthesia in accordance with the product labeling precautions.

Event Description

The customer reported that the anesthetist did not recognize the product as an injectable device, presuming that it was a plain cap, and therefore did not flush the line post administration of anesthesia.The report suggests that when the cannula was flushed later on when the patient was on the ward post-surgery, they received a small residual amount of the anesthetic drug, which caused respiratory distress.There is no report of any medical intervention required and no report of any lasting harm.

• 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
• 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: 6216080
• MDR Text Key: 63661634
• Report Number: 9616066-2016-01906
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2000E7D
• Device Catalogue Number: 2000E7D
• Other Device ID Number: 2000E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other