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

Model Number	306546
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: bedside report and ivf [intravenous fluid] rates being verified.Leaking fluid noted from medication line filter that is attached to picc [peripherally inserted central catheter].Liquid noted at site of filter, soaked label on the line and droplets noted along med line.Nothing infusing via med line at this time.Medication line had been changed the previous shift.

• Brand Name: BD POSIFLUSH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 1 becton dr.; franklin lakes NJ 07417
• MDR Report Key: 23356630
• Report Number: 23356630
• Device Sequence Number: 15668738
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 10/01/2025
• Report Date (Section F): 10/01/2025

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
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 5065644
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• 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
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 3 KG
• Date Report Sent to FDA: 10/01/2025