MAUDE Adverse Event Report: CAREFUSION NEUTRACLEAR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PB-NC5302

Device Problem Material Deformation (2976)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: medrad pressure infusion equipment; therapy date (b)(6) 2018.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 while performing a cta of the pulmonary arteries with a non-bd power injector it pressured out at 4ml/second while injecting isovue 370 (which ranges from 80ml-100ml based on patient weight and procedure) along with a 25ml ns flush.The slide clamp on the tubing caused the tubing to remain crimped after it was released, which prevented a full dose of the medication from being delivered.This caused the patient to receive additional medication to complete the procedure, and an additional ct scan.There was no lasting harm.

Manufacturer Narrative

The customer¿s report of a crimp in the tubing was confirmed but was determined to be unrelated to the power injection issue.The report of increased pressure (restricted flow) was confirmed.Visual inspection showed a kink/crimp in the tubing approximately 6.5mm from the male luer.Functional testing showed that the high pressure is due to an incompatibility between the concomitant non-bd pressure injector syringe and tubing and the neutraclear valve.The male luers of the non-bd syringe and pressure injector tubing have a section with an internal diameter of 1.35mm.The neutraclear directions for use state that the neutraclear needle-free connector is compatible with iso 594 certified luers with an internal diameter larger than 1.5mm.The concomitant device male luer is incompatible and caused restricted flow through the neutraclear.The kink/crimp in the tubing due to the engagement of the slide clamp is normal and does not lead to a loss of flow or a rise in pressure.The root cause of the restricted flow is an incompatibility between the neutraclear connector and the male luers of the mating products.

• Brand Name: NEUTRACLEAR EXTENSION SET
• 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: 7446992
• MDR Text Key: 106059645
• Report Number: 9616066-2018-00461
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB-NC5302
• Device Catalogue Number: PB-NC5302
• Device Lot Number: 17125-T
• Other Device ID Number: 10885403425479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 122