MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Contamination (1120)

Patient Problem Vitreous Floaters (1866)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.D.3.Franklin lakes has been listed as the manufacturer.E.4.The initial reporter also notified the fda on 31-oct-2023.Medwatch report is mw5147782.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd syringe had silicone droplets.The following information was provided by the initial reporter: "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." additional information received on 01/02/2024: "thank you for responding to my complaint.The additional information that you have requested may be in my medical chart that was maintained by dr (b)(6) md.He was my ophthalmologist in (b)(6).The name of the practice is (b)(6).I was diagnosed with wet macular degeneration in (b)(6) 2017 and received my first injection of avastin with your bd syringe at that time.It was the first injection that i received , in which is now known as, an oil droplet from the oil in the bd syringe.It was only this year that i was told there was an " issue" with the combination of the avastin and bd syringes.After further research, i found that i too had retained an oil droplet in my right eye that is consistent with noted complaints.There are no photos as i am told all scans done over the years would not reveal a floating oil droplet.I do not need to confirm the exact defect as the details are all in the confirmation and complaints that were lodged when oil droplets became apparent in other patients in 2016 -2017 investigations.As i have stated earlier, a medwatch form and a complaint to the fda was submitted by me this year.I¿ve lived with this oil droplet now for 7 years.Avastin states that they are not responsible for this defect in my right eye after submitting all medical records to their team.This is not ¿feedback¿.This is a formal complaint to your company and i will withhold contacting my lawyer until i hear from you again.".

• Brand Name: BD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18494165
• MDR Text Key: 332726328
• Report Number: 2243072-2023-02298
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other