MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	383557
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was brought to ed for intermittent rlq [right lower quadrant] abdominal pain for 3 days.Per ed-md's notes: patient will need admission for further workup and management; admitted in stable condition.Patient needed iv fluids as ordered by md.As they were inserting the iv, they noticed that there was fluid on the rn's gloves.Further investigation showed a leak at the seal area.Device was exchanged for another similar device, and the procedure was completed with no further incident.No patient harm.Manufacturer response for catheter,intravascular,therapeutic,short-term less than 30 days, bd nexiva (per site reporter) the supplies with the same lot numbers have been given to materials management manager by ed-rn manager.

• Brand Name: BD NEXIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 17200 laguna canyon rd; irvine CA 92618
• MDR Report Key: 25778527
• Report Number: 25778527
• Device Sequence Number: 9607968
• Product Code: FOZ
• UDI-Device Identifier: 00382903835577
• UDI-Public: (01)00382903835577(17)281130(10)5363135
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026
• Report Date (Section F): 05/28/2026

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 Model Number: 383557
• Device Catalogue Number: 383557
• Device Lot Number: 5363135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Date Report Sent to FDA: 05/28/2026