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

Catalog Number 383606

Device Problem Flushing Problem (1252)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown, no lot # provided, (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use a bd nexiva¿ closed iv catheter system malfunctioned as the ¿nurse was flushing nexiva after insertion.The extension set began to bubble and wouldn't flush.Nexiva cannula removed and another inserted.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: dhr review: a review of the dhr could not be performed as no batch number was provided for this incident.Qn database review: not required for level a investigation.Eura review: the defective unit was not returned for evaluation and testing; therefore root cause of the defect is indeterminate.Based on the customer's verbatim description, the effect of the defect was two or more piv insertions.Rm5769 rev 13(l) nexiva a-eura identifies ballooned tubing as a failure mode and two or more piv insertions as an effect with limited severity of s2.Occurrence of the defect could not be established for this batch as no lot number was provided.However, with low occurrence (=100 ipm) and limited severity, the risk to the end user is acceptable.Investigation conclusion: sample analysis - examination of the photos submitted by the customer show a nexiva unit with evidence of ballooned extension tubing.The customer's experience was confirmed by the photo.Root cause is indeterminate.Occlusion of the fluid pathway (e.G.Occluded catheter, kinked tubing, pinch clamp engaged during infusion) will increase the internal pressure of the unit and can cause the extension tubing to break, balloon, and/or burst.D16123 rev6(c) nexiva dual port instructions for use advises that measures should be taken to avoid kinking or obstructing the catheter system during power injection to avoid product failure.Burst or ballooning damage to the tubing can also occur if infusion is not performed correctly or performed at a psi/flow rate above the recommendations listed in d16123 rev6(c) nexiva dual port instructions for use.

• 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: 7307878
• MDR Text Key: 101657300
• Report Number: 1710034-2018-00064
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835325
• UDI-Public: 30382903835325
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• 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: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 383606
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other