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

Catalog Number	305761
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 25x1 rb had foreign matter.It was reported by customer that they noted a substance inside the orange needle hub.Verbatim: rcc received a complaint via community.Pir attached clinical staff memeber opened the package of the needle and noted a substance inside the orange needle hub.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed black foreign matter inside the needle hub.The foreign matter was sent for fourier transform infrared spectroscopy (ftir) analysis to determine the type.The results show that the spectrum matches reasonably with silicone.Silicone is used as lubrication for the cannula in the assembly process.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.During product changeover, empty racks are used to segregate the previous lot from the new lot.As these racks proceed through subsequent manufacturing steps, the deposited silicone can accumulate or entrap fine particulates, ultimately leading to the black silicone gel observed in the reported sample.To prevent this defect, a one-point lesson will be created to train the production technicians to deactivate the lubricant dispensing function during changeover activities.

• Brand Name: ECLIPSE
• 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; dorcan; singapore SN3 5 JH; UK SN3 5JH
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23853642
• Report Number: 2243072-2025-01524
• Device Sequence Number: 9543775
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610(11)250617(17)300531(10)5167186
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 305761
• Device Lot Number: 5167186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown