MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Nexiva; Intravascular Catheter

Catalog Number	393527
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
It was reported that during use, a nexiva nearport iv leaked during flushing.Upon closer inspection, the device was observed to have separated at the junction of the extension tubing and the hub, with the hub detached from the tubing.A photograph of the reported device condition was provided to support the investigation.Review of the photograph showed the port assembly and hub separated from the extension tubing, consistent with the reported event.The affected device was not available for return and evaluation.As a result, the investigation was limited to the information and photographs provided, and a definitive root cause could not be determined.A lot number was not provided with the complaint and could not be identified from the photographs received.Consequently, a device history review could not be performed.The information provided for review was consistent with the reported device condition.However, because the affected device was not available for examination, the underlying cause of the separation could not be determined.The details associated with this event have been documented within our quality system and will be handled in accordance with established complaint management processes.

• Brand Name: Nexiva
• 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 ; +1(847)393-5694
• MDR Report Key: 50225465
• Report Number: 9610847-2026-00341
• Device Sequence Number: 21405621
• Product Code: FOZ
• UDI-Device Identifier: 00382903935277
• UDI-Public: (01)00382903935277
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231239
• 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): 10/01/2026

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: 393527
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown