MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN 30G INJECTION NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	UNKNOWN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that non- bd product was reported, and the complaint will be cancelled.The associated mdr will be void.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material: unknown 30g injection needle batch#: unknown verbatim: the report states, "syringe leaked when priming needle for treatment." confirmed via phone call to the eye clinic that the leak occurred between the needle and the syringe after the filter needle was removed and a 30 gauge needle was attached.No visible cracks on the syringe it was confirmed by the hcp that there was no harm to the patient or the caregiver.

• Brand Name: UNKNOWN 30G INJECTION NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21411492
• Report Number: 1911916-2025-00126
• Device Sequence Number: 18221969
• Product Code: FMI
• UDI-Device Identifier: 30382903052005
• UDI-Public: (01)30382903052005
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• 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,Followup
• Report Date (Section B): 02/23/2025

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown