MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.75 IN; INTRAVASCULAR CATHETER

Model Number 383518

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Pain (1994)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system ¿ single port 20 ga 1.75 in experienced catheter splitting.The following information was provided by the initial reporter: product malfunction of ref 383518 bard nexiva closed iv catheter system 20g 1.75 in 1/1 x 45 mm.Used ultrasound to assist m placement of peripheral iv.During insertion of iv catheter, the plastic catheter split.Patient expressed feelings of pain and discomfort at that time.After withdrawing the iv from the unsuccessful iv placement attempt, this rn noted that the plastic catheter split apart from the needle during insertion.

Manufacturer Narrative

Device expiration date: unknown.Fda notified: the initial reporter also notified the fda via medwatch #: (b)(4).Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.75 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12628256
• MDR Text Key: 284383694
• Report Number: 1710034-2021-00883
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: 30382903835189
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383518
• Device Catalogue Number: 383518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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