MAUDE Adverse Event Report: BD BD SYRINGE; SYRINGE, PISTON

Patient Problems Vitreous Floaters (1866); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

First injection of avastin for wet macular degeneration with bd syringe by retinologist has left me with a silicone oil floater in my right eye.After years of stating that i have an "air bubble" in my right eye, i was informed there was an issue with avastin and oil droplets when used with a bd syringe.

• Brand Name: BD SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 18074451
• MDR Text Key: 327533647
• Report Number: MW5147782
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ALBUTEROL.; AVASTIN.; CALCIUM.; LIPITOR.; SPRIVA.; TYLENOL.; VIT D.
• Patient Outcome(s): Disability
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White