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	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: when the rn caring for infant was checking the lines, it was noted the medication tubing was wet.When going to hang an iv medication the rn hung new tubing.Upon shift change and nurse hand off the new tubing was also noted to be wet.Upon further investigation the tubing was noted to be leaking around the filter or possibly the filter being cracked, and packaging was saved to follow lot number (#14329474).The previous tubing was also retrieved and investigated to also be leaking around the filter.All tubing with similar lot numbers set aside on the unit until further evaluation of issue.

• 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: 23554600
• Report Number: 23554600
• Device Sequence Number: 10160788
• 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): 10/21/2025
• Report Date (Section F): 10/21/2025

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: 5162459
• 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: 11/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• 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: 10/21/2025