MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number 383512

Device Problems Leak/Splash (1354); Material Perforation (2205)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

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 while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in there was a hole in the catheter and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: please see 22 ga nexiva, ref (b)(4), lot# 2182272.The catheter/needle were discarded so we don¿t have product to return, unfortunately.22g nexiva catheter used to start piv in right forearm.Catheter was mostly advanced when needle was removed.Noted bleeding from site.Gentle pressure held at site for a few seconds and bleeding stopped.Catheter flushed with ns and noted leaking at site.Catheter pulled back a little and noted small hole in catheter.Catheter removed and piv started in new vein.Catheter was bd nexiva 22g x1" lot number 2182272 ref (b)(4).

Event Description

It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in there was a hole in the catheter and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: please see 22 ga nexiva, ref 383512, lot# 2182272.The catheter/needle were discarded so we don¿t have product to return, unfortunately.22g nexiva catheter used to start piv in right forearm.Catheter was mostly advanced when needle was removed.Noted bleeding from site.Gentle pressure held at site for a few seconds and bleeding stopped.Catheter flushed with ns and noted leaking at site.Catheter pulled back a little and noted small hole in catheter.Catheter removed and piv started in new vein.Catheter was bd nexiva 22g x1" lot number 2182272 ref #383512.

Manufacturer Narrative

H6: 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.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN
• 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 ; 8448235433
• MDR Report Key: 17080917
• MDR Text Key: 317588491
• Report Number: 1710034-2023-00634
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: (01)30382903835127
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383512
• Device Catalogue Number: 383512
• Device Lot Number: 2182272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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