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

Model Number 383539

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

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 by the customer that during use of the bd nexiva¿ closed iv catheter system upon examining the catheters it appeared "that there is a very little piece of extra plastic sticking out of the tip of the catheter.Verbatim: "we are experiencing resistance in puncturing the skin ¿ feels like trying to puncture leather.I thought that perhaps it was due to patient¿s skin thickness, but i had the same problems starting iv¿s using the catheters from the same lot.Other nurses in day surgery are experiencing the same thing.I did examine the catheters and it appears that there is a very little piece of extra plastic sticking out of the tip of the catheter.".

Manufacturer Narrative

Investigation summary 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.

Event Description

It was reported by the customer that during use of the bd nexiva¿ closed iv catheter system upon examining the catheters it appeared "that there is a very little piece of extra plastic sticking out of the tip of the catheter.Verbatim: "we are experiencing resistance in puncturing the skin ¿ feels like trying to puncture leather.I thought that perhaps it was due to patient¿s skin thickness, but i had the same problems starting iv¿s using the catheters from the same lot.Other nurses in day surgery are experiencing the same thing.I did examine the catheters and it appears that there is a very little piece of extra plastic sticking out of the tip of the catheter.".

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15035062
• MDR Text Key: 296153626
• Report Number: 1710034-2022-00371
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835394
• UDI-Public: 30382903835394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383539
• Device Catalogue Number: 383539
• Device Lot Number: 2005335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1