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

Catalog Number 383516

Device Problem Difficult to Remove (1528)

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

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd nexiva¿ closed iv catheter system is difficult to pull out.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 383516.Batch/lot: 8319930.It was reported that when the product is pulled out, something seems to be catching.Customer text: we are having some issues with item# 383516 20ga lot number 8319930 that when they pull it out something seems to be catching.

Event Description

It was reported that bd nexiva¿ closed iv catheter system is difficult to pull out.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 383516.Batch/lot: 8319930.It was reported that when the product is pulled out, something seems to be catching.Customer text: we are having some issues with item# 383516 20ga lot number 8319930 that when they pull it out something seems to be catching.

Manufacturer Narrative

Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and a root cause was not determined.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8499289
• MDR Text Key: 141956501
• Report Number: 1710034-2019-00396
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: 30382903835165
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 383516
• Device Lot Number: 8319930
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other