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 in interventional radiology department initially to have paracentesis; however, patient was noted to have hypotension bp 89/60 and was brought to ed.Patient needed iv fluids as ordered by ed-md and referred to hospitalist for admission/ further assessment.When iv fluid was inserted, rn noted fluid dripping on to her gloves.Iv was halted and upon closer investigation, leakage was noted at the seal area.Device was exchanged for another similar device and the procedure was completed without further incident.No patient harm.Manufacturer response for catheter,intravascular,therapeutic,short-term less than 30 days, bd nexiva (per site reporter) supplies with the same lot number 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: 25778438
• Report Number: 25778438
• Device Sequence Number: 9625786
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Date Report Sent to FDA: 05/28/2026