MAUDE Adverse Event Report: NEXIVA DIFFUSICS 20G X 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number	383593
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that nexiva diffusics 20g x 1.25 in catheter kinked.This occurred on 3 occasions.The following information was provided by the initial reporter: it was reported that nurse could feel the catheter bent and outside of the vein - when i took the catheter out i was able to see where it was bent in her arm.  verbatim: i placed a 20g iv in pt's l ac with the new ivs, bd nexiva diffusics.When originally placed line worked great.When taken to ct line would not work.When i felt the pt's arm i could feel the catheter bent and outside of the vein.When i took the catheter out i was able to see where it was bent in her arm.Pt has been in pain and moving frequently.I placed a new line and pt was able to get her ct.This is the third time i have had something similar happen.These iv catheters seem to be coming out of the veins and bending in the pt's arms after they have been moving around.This has the potential to cause infiltrations if pt's are receiving infusions or drips and they move around.
Additional 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that nexiva diffusics 20g x 1.25 in catheter kinked.This occurred on 3 occasions.The following information was provided by the initial reporter: it was reported that nurse could feel the catheter bent and outside of the vein - when i took the catheter out i was able to see where it was bent in her arm.  verbatim: i placed a 20g iv in pt's l ac with the new ivs, bd nexiva diffusics.When originally placed line worked great.When taken to ct line would not work.When i felt the pt's arm i could feel the catheter bent and outside of the vein.When i took the catheter out i was able to see where it was bent in her arm.Pt has been in pain and moving frequently.I placed a new line and pt was able to get her ct.This is the third time i have had something similar happen.These iv catheters seem to be coming out of the veins and bending in the pt's arms after they have been moving around.This has the potential to cause infiltrations if pt's are receiving infusions or drips and they move around.

• Brand Name: NEXIVA DIFFUSICS 20G X 1.25 IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12345975
• Report Number: 9610847-2021-00384
• Device Sequence Number: 3834697
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: 00382903835935
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 383593
• Device Lot Number: 1053969
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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