MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number 383590

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 02/03/2023

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system will not advance.The following information was provided by the initial reporter: when this type of iv catheter is placed in a child or infant without extra tape under the iv securment device (tegaderm), the catheter backs out.Sometimes we are able to re thread iv catheter and re tape the iv using 2 pieces of tape to create a cheveron under the tegaderm.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: since no photos or samples displaying the reported condition of catheter backs out of vein were available for examination, we were unable to fully investigate this incident.Dhr for this lot was reviewed and there are no internal rejects related to the reported issue by the customer.According to the quality records all the inspections of the sampling plan met the acceptance criteria.

Event Description

It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system will not advance.The following information was provided by the initial reporter: when this type of iv catheter is placed in a child or infant without extra tape under the iv securment device (tegaderm), the catheter backs out.Sometimes we are able to re thread iv catheter and re tape the iv using 2 pieces of tape to create a cheveron under the tegaderm.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16475553
• MDR Text Key: 310973799
• Report Number: 9610847-2023-00046
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835905
• UDI-Public: (01)30382903835905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383590
• Device Catalogue Number: 383590
• Device Lot Number: 1218722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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