MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 20G X 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number	383593
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics 20g x 1.25 in had connection issues it was reported by customer that bd nexiva diffusics 20 ga x 1.25 in closed iv catheter system.The pre-attached extension tubing dislodged from the stabilization platform after starting the iv on the patient.I was able to tamponed the vein and remove the catheter assembly with only a few cc blood verbatim#: rcc received a complaint via email.Email(s) attached.Item: 383593 quantity affected: (b)(4) ea serial/lot number: (b)(6) po : (b)(6).Are any samples available for return? yes reported issue: bd nexiva diffusics 20 ga x 1.25 in closed iv catheter system.The pre-attached extension tubing dislodged from the stabilization platform after starting the iv on the patient.I was able to tamponed the vein and remove the catheter assembly with only a few cc blood.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of connection issues was confirmed upon inspection of the samples.Analysis of the sample showed that the defect reported by the user, separation can be observed in catheter adapter, tube joint.However, bd was not able to determine the cause of the failure as no sample was returned for analysis.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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
No additional information.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA DIFFUSICS 20G X 1.25 IN
• Common Device Name: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20535454
• Report Number: 9610847-2024-00327
• Device Sequence Number: 17835926
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: (01)00382903835935(11)240513(17)270430(10)2356441
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2025

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: Health Professional
• Device Catalogue Number: 383593
• Device Lot Number: 4124921
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 12/23/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/31/2024; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown