MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305761
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
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 was reported that bd needle eclipse 25x1 rb - safety mechanism failure.It was reported by customer that safety device not preattached to needle hub leaving needle exposed with no way to safely cap and dispose of.
Additional Manufacturer Narrative
Our quality engineer inspected the video and photo submitted for evaluation.The reported issue of safety mechanism failure was not confirmed upon inspection of the video.Analysis of the video showed the safety shield was already detached from the eclipse hub.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.From the video, it was observed that the safety shield was already detached from the eclipse hub so the root cause was unable to be determined.The user demonstrated the activation method by gripping the sides of the safety shield.This suggests that user-related factors may have contributed to the reported issue.

• Brand Name: NEEDLE ECLIPSE 25X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23014228
• Report Number: 2243072-2025-01141
• Device Sequence Number: 21225809
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610(11)240909(17)290831(10)4237565
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• 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): 10/09/2025

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: 305761
• Device Lot Number: 4237565
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown