MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383519

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use a bd nexiva¿ closed iv catheter system was found with difficult needle disengagement as "a nexiva catheter was used by an ed nurse and the needle would not come out.The patient had to be stuck again." there was no report of exposure, injury or medical intervention needed.

Event Description

It was reported that during use a bd nexiva¿ closed iv catheter system was found with difficult needle disengagement as "a nexiva catheter was used by an emergency department nurse and the needle would not come out.The patient had to be stuck again." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: device/batch history record review shows the lot was built and packaged on nfa line 1 from 15aug17 through 17aug17 for the quantity of 181,450ea.All required challenge, set up and in process samples were performed according to the quality plan and all passed per specifications.One non related qn (200704463 ¿ suspect occluded cannula) was initiated and disposition of the product, root cause and corrective action were applied according to the quality control plan.End user risk analysis (eura) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.Observations and testing: received 1 nexiva 18ga used unit within a specimen bottle with a piece of top web (packaging) from lot number 7223595.The unit had traces of blood throughout its components.Simulation test (disengagement): simulation test in an attempt to recreate the customer¿s experience.The unit successfully disengaged and the adapter was released without resistance, the needle was not bent and no signs of adhesive or physical-mechanical damage was found on any of the components of the unit.Root cause for to the reported incident is indeterminate.The failure described in the incident report could not be confirmed or recreated in the laboratory.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7603117
• MDR Text Key: 111716101
• Report Number: 1710034-2018-00334
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835196
• UDI-Public: 30382903835196
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 383519
• Device Lot Number: 7223595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other