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

Catalog Number	383591
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that "iv blew apart while injecting saline flush" verbatim: complaint via email.Email(s) attached medical device problem report to vendor request for lot/complaints review alberta mdip # 15546 device available for investigation: no please see the below device problem report.No serious harm was reported.Unfortunately, the device is not available for investigation.A production lot review (when lot number provided) and a summary report of complaints, problems and incidents (including level of harm) associated with this device is requested, to be provided within ninety (90) days.Next steps ¿ your actions please reference the alberta mdip (indicated above) in all communication associated with this mdip and copy me in all communication.Provide your file/reference number for this mdip report.Please send me the final report and copy the primary clinical contact and manager (see names below), as well as (b)(6).Provide replacement or credit details as appropriate and advise once credit or replacement has been completed.Please do not reach out with automated, redundant or unnecessary questions about the problem, event or device.Should you require information that has not already been provided in order to help the investigation and/or improve the device or its manufacturing, please send me those specific questions.Ongoing feedback about this device will be tracked and trended.Should additional important information about this device or problem become available, this information will be shared with you.Thank you for participating in the alberta medical device safety incident or problem reporting and investigation process.Please contact me if you have any questions.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: NEXIVA DIFFUSICS
• 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): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24904050
• Report Number: 9610847-2026-00166
• Device Sequence Number: 9067262
• Product Code: FOZ
• UDI-Device Identifier: 00382903835911
• UDI-Public: (01)00382903835911(11)251031(17)280930(10)5281689
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 383591
• Device Lot Number: 5281689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown