MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 3ml BD Plastipak; Syringe, Piston

Model Number	Plastipak
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2026
Type of Reportable Event	Other
Event or Problem Description
Upon preparing syringe for injection it was noted the stopper on the plunger was offset this made drawing the medication up into syringe difficult as well as altered the visual for correct dosing.The syringe was 3ml bd plastipak.

• Brand Name: 3ml BD Plastipak
• Common Device Name: Syringe, Piston
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 50130044
• Report Number: MW6000395
• Device Sequence Number: 15800930
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: Plastipak
• Device Lot Number: 6006180
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male