MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1/2ML W/NDL 27X1/2 RB; Syringe, piston

Catalog Number	305620
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 1/2ml w/ndl 27x1/2 rb had visible droplets (silicone).The following information was provided by the initial reporter: "dr.Xxx is a retina specialist - this product is used to treat patients with wet macular degeneration.They use this to do intravitreal injections into the eye.They are production silicone bubbles.Dr wants to know if there is some alternative syringe comparable to this one that we sell.It has been an ongoing thing, so there was not an exact date of the incident or number of times it has happened that were provided.".

• Brand Name: BD SYRINGE 1/2ML W/NDL 27X1/2 RB
• Common Device Name: Syringe, piston
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18167215
• Report Number: 1920898-2023-00778
• Device Sequence Number: 20636812
• Product Code: FMF
• UDI-Device Identifier: 30382903056201
• UDI-Public: (01)30382903056201
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

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: Other
• Device Catalogue Number: 305620
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown