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	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 393526.Batch # 5237880.It was reported by customer that flush through main lumen, but fluid leaked through near port 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.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: bd was not able to confirm the customer¿s indicated failure mode because no samples or pictures were received to perform investigation.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 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: 23438165
• Report Number: 9610847-2025-00395
• Device Sequence Number: 20970506
• Product Code: FOZ
• UDI-Device Identifier: 00382903935260
• UDI-Public: (01)00382903935260(11)250905(17)280731(10)5237880
• 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: 5237880
• 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: 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
• Date Device Manufactured: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown