MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD PosiFlush; Saline, vascular access flush

Model Number	306546
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
After placing piv "[peripheral iv]" and flushing lumen to check patency, saline flush was removed from the connection point to connect the patient to the fluid line.Upon removing flush, there was a very slight amount of resistance.When the flush came off, the inside part of the flush connection was stuck inside of the connection site on the iv.This piece was lodged into the iv and unable to be removed.Piv had to be removed from patient, and a new piv was placed for treatment.

• Brand Name: BD PosiFlush
• Common Device Name: Saline, vascular access flush
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 50115656
• Report Number: 50115656
• Device Sequence Number: 10264711
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: (01)00382903065462
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/24/2026
• Report Date (Section F): 07/24/2026

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: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 6042090
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 07/24/2026