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

Model Number CAD_NFV

Device Problem Leak/Splash (1354)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/19/2019

Event Type  Injury  

Manufacturer Narrative

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

It was reported that blood splattered onto the rn's face when the rn was disconnecting the bd 10ml syringe from the maxzero after completing a lab draw from the adult patient's picc line.The customer further stated that they are aware that bd recently announced an update to the directions of use (dfu) stating "when disconnecting a luer-lock or luer-slip syringe or tubing set from the maxzero connector, carefully rotate the luer counterclockwise a 360-degree turn using a controlled motion, to minimize fluid escaping¿ in which they validated that the rn rotated the cap per the recent dfu update.The customer later stated that there were no adverse effects caused to the patient from the event, however the nurse was required to follow the facility blood and body fluid protocol.

• Brand Name: 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8877238
• MDR Text Key: 153788567
• Report Number: 9616066-2019-02208
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAD_NFV
• Device Catalogue Number: CAD_NFV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: PICC, 10ML BD SALINE FLUSH SYRINGE, TD: (B)(6) 2019.
• Patient Outcome(s): Required Intervention