MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It is reported broken needle.Event description: material # 305106, batch # 3334821.On (b)(6) 2025 regeneron was informed of an event with eylea 8mg vial kit which was categorized with the defect component issue ci - broken filter needle.The office staff reported the following: ¿the needle broke off the syringe when the physician was attempting to switch needles while preparing an eylea hd dose on (b)(6) 2025.She explained the plastic part at the base of the syringe where the needle attaches broke off when the physician went to ¿twist or pull¿ the filter needle off.¿.
Additional Manufacturer Narrative
(b)(4) follow up: a needle breakage was reported.As a physical sample was not returned, a thorough sample evaluation could not be performed.To support the investigation, one photograph was provided and reviewed by the quality team.The image depicts a syringe with a needle hub attached.No additional information could be obtained from the photograph alone.A device history record (dhr) review was conducted for material number 305106, lot 3334821.The review did not identify any quality issues during the manufacturing process that could have contributed to the reported condition.No related quality notifications were found, and all production processes and final inspections were performed in accordance with specification requirements.To date, no similar complaints have been reported for this lot.Based on the available photograph, the reported symptom has been confirmed.However, due to the absence of a physical sample, a probable root cause could not be determined.

• Brand Name: NEEDLE 30X1/2 RB
• 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: 22827862
• Report Number: 1911916-2025-00589
• Device Sequence Number: 19974587
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290131(10)3334821
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 305106
• Device Lot Number: 3334821
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown