MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	393526
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
Material # 393526 batch # 5237880 it was reported by customer that flush through main lumen, but fluid leaked through near port.Verbatim: customer shared that there were two incidents that the iv would not flush despite being placed and used successfully.Attempted to flush through main lumen but fluid leaked through nearport.(b)(6) utilized a 20 g nexiva iv catheter on a patient tonight (lot # 5237880 exp date 7-31-28) and after approximately 3 hours of regular use including a ct with contrast she found she was no longer able to flush the line property.When she attempted to trouble shoot the iv she found that when she attempted to flush the line the saline was spraying out of a tiny hole in the hub nearest to the iv-insertion point.(b)(6) says this has happened to her on at least one other iv set in the past.No pivo was used at that site and nothing was down to it that would explain where the small hole came from.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was not performed as the lot number is unknown for this complaint.A device history record review was not performed as the lot number is unknown for this complaint.There are proper controls in place to detect product malfunctions.

• Brand Name: NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 23438156
• Report Number: 9610847-2025-00396
• Device Sequence Number: 8552685
• Product Code: FOZ
• UDI-Device Identifier: 00382903935260
• UDI-Public: (01)00382903935260
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/28/2025

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: 393526
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown