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

Model Number EL-NC1001

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597); Failure to Disconnect (2541)

Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2018

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that the neutraclear connector broke into several pieces when disconnecting from the medication line on a central venous pressure line (cvp).When the connector broke, it left a piece of the connector stuck to the cvp line.The rn was required to prime a new central venous line and the physician replaced the cv line in order to be able to infuse the ordered fluids.A new tubing set was primed and attached to the patient to complete the medication drip.There was no patient harm.

• Brand Name: NEUTRACLEAR NEEDLE-FREE CONNECTOR
• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7567331
• MDR Text Key: 110028346
• Report Number: 9616066-2018-00628
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL-NC1001
• Device Catalogue Number: EL-NC1001
• Other Device ID Number: 10885403463907
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• 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
• Patient Outcome(s): Required Intervention