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

Catalog Number	383579
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the blood flowed past the cap and freely out of the iv line.Can you please provide an exact date of event in format mm-dd-yyyy? event 1: 4/18/2026, 24g nexiva diffusics ¿ sample not retained event 2: 4/10/2026, nexiva 20g dual port event 3: 03/13/2026, nexiva 18g lot: 5310149.Event 4: 02/09/2026, nexiva 20g dual port ¿ samples retained, can you please provide the material and lot number associated with reported issue? event 1: 24 guage leaking and saturated, event 2: vent plug fell off during insertion and exposed the clinician to blood.Clinician stared this has happened multiple times during insertion.Event 3: event 4: needle is upside-down and this is how they arrive out of the package.Lot#: 5310143, any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Event 1: no event 2: no, event 3: no event 4: no could you please confirm if any samples are available for return so we can investigate further? event 1: no, event 2: no, event 3: no event 4: 11 cases pulled from value analysis.Please provide 11 shipping labels for all samples to be returned.814 each was there any leak? event 1: yes ¿ leaking was reported at the hub of the iv but no samples were retained for diagnostics.
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 MAXZERO
• 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: 25150363
• Report Number: 9610847-2026-00201
• Device Sequence Number: 21181405
• Product Code: FOZ
• UDI-Device Identifier: 00382903835799
• UDI-Public: (01)00382903835799(11)251202(17)281031(10)5310149
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 383579
• Device Lot Number: 5310149
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown