MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. NEXIVA DIFFUSICS; PERIPHERAL IV CATHETERS

Catalog Number	383590
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K173354; k250682.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that the nexiva diffusics leaked.Date of incident: (b)(6) 2026.Level of harm: temporary harm.No serious harm was reported.Incident details: staff nurse went to place piv, upon initial poke, blood began leaking through the iv cannula at the base.Iv attempt was aborted and 2nd iv attempt was gained.Who was affected? patient.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: bd was not able to confirm the customer¿s indicated failure mode because no samples or pictures were received to perform investigation.It is recommended to provide a sample exhibiting the reported defect for evaluation.The manufacturing records for this batch has been reviewed and nothing extraordinary occurred during the manufacturing process related to this failure mode.Internal quality records have been consulted for tracking and trending purposes but issues like this are not detected which means low occurrence.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.

• Brand Name: NEXIVA DIFFUSICS
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: 24716825
• Report Number: 9610847-2026-00142
• Device Sequence Number: 12283931
• Product Code: FOZ
• UDI-Device Identifier: 00382903835904
• UDI-Public: (01)00382903835904(11)251110(17)281031(10)5302322
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 383590
• Device Lot Number: 5302322
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown