MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 20GA 1.25IN; INTRAVASCULAR CATHETER

Catalog Number	383537
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
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.
Event or Problem Description
It was reported that bd nexiva 20ga 1.25in leaked.During insertion of the bd nexiva iv catheter post removal of stylet, there was leakage of the blood from the catheter hub site (point from the stylet is taken out).As post removal of the stylet, it should be automatic sealed through its closed value, but due to some malfunction the blood leaked from that side.Issue: blood leakage observed from the catheter hub upon removal of the stylet expected outcome: the catheter hub should auto-seal post stylet removal actual outcome: blood leakage occurred potential blood exposure to the patient required cannula re-siting current status: the er team at xxxxx is utilizing nexiva, and this issue has raised concerns regarding patient safety and procedural efficiency.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of leakage was not confirmed upon inspection of the photos.Bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD NEXIVA 20GA 1.25IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22304547
• Report Number: 2243072-2025-00777
• Device Sequence Number: 17246651
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: (01)00382903835379(11)241002(17)270930(10)4270642
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 383537
• Device Lot Number: 4270642
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/22/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown