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

Model Number EL-NC1001

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Pain (1994)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the neutraclear piston/gland was stuck and remained in the down position which caused the chemotherapy to be unable to infuse.The nurse held the infusion, flushed the port with normal saline and reconnected the tubing set to find that the piston/gland was stuck in the down position.The neutraclear valve was changed and the piston/gland for the second neutraclear valve was also stuck and remained in the down position.The neutraclear was replaced again with a third neutraclear valve with no further reports of complications.The patient complained of pain at the port site and experienced multiple unnecessary line entries.There was no lasting harm caused to the patient.

Event Description

It was reported that when the patient complained of pain at the port site during a vincristine chemotherapy infusion, the nurse flushed the port with normal saline and reconnected the chemotherapy infusion tubing set; however the chemotherapy agent would not infuse because the orange piston of the neutraclear valve remained depressed after the syringe was removed.The neutraclear valve was reported to have been in use for less than 2 hours.The nurse disconnected the chemotherapy tubing set and changed the neutraclear valve; the second neutraclear valve remained depressed as well.The valve was changed again without any further complications.The nurse further stated that she spent one hour in the patient room to administer a 5 minute and 15 minute chemotherapy infusion, including multiple and unnecessary line entries.There was no lasting harm caused to the patient.

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

• 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
• MDR Report Key: 8022309
• MDR Text Key: 125589022
• Report Number: 9616066-2018-02026
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K171117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR