MAUDE Adverse Event Report: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.75 IN; INTRAVASCULAR CATHETER

Model Number	383518
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12628256
• Report Number: 1710034-2021-00883
• Device Sequence Number: 3421621
• Product Code: FOZ
• UDI-Device Identifier: 30382903835189
• UDI-Public: 30382903835189
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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
• Operator of Device: Other
• Device Model Number: 383518
• Device Catalogue Number: 383518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1