MAUDE Adverse Event Report: BD / BECTON DICKINSON INTEGRA SYRINGE; SYRINGE, ANTISTICK

Model Number	305274
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While giving an injection with a bd integra syringe, the metal tip of the plunger broke through the plunger stopper.As a result, the patient received less than a full dose of medication.Fda safety report id # (b)(4).

• Brand Name: INTEGRA SYRINGE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD / BECTON DICKINSON
• MDR Report Key: 15401801
• Report Number: MW5111968
• Device Sequence Number: 6952236
• Product Code: MEG
• UDI-Device Identifier: 00382903052745
• UDI-Public: (01)00382903052745
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 305274
• Device Lot Number: 1029961
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2022
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White