MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 30X1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305106
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation it was reported that there was an insecure needle syringe connection.Because no physical sample was returned, a comprehensive evaluation could not be performed.To support the investigation, three photographs were provided for review by the quality team.The images show a needle with the plastic shield assembled to a syringe, no additional information could be obtained from the photographs.A device history record review was completed for material number 305106, lot 4081033.The review did not reveal any quality issues during production of this lot that could have contributed to the reported condition.There were no related quality notifications, and all in process controls and final inspections were performed per specification requirements.Based on the available information, including the photographic assessment, the reported condition could not be confirmed.In the absence of a returned sample, a probable root cause could not be determined.
Event or Problem Description
It is reported connection issues.Verbatim: material 305106 batch 4081033 on 08sep2025 regeneron was informed of an event with eylea 8mg vial kit which was categorized with the defect component issue ci insecure needle-syringe connection on 08sep2025, the office staff reported the following: there was a faulty syringe for the doctor.When he was trying, it wasn't clicking and it was loose.

• Brand Name: NEEDLE 30X1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 24118113
• Report Number: 1911916-2026-00020
• Device Sequence Number: 12258921
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290531(10)4081033
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 01/12/2026

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: 305106
• Device Lot Number: 4081033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown