MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305764
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 21x1 rb tw had foreign matter.It was reported by customer that they had a contaminated needle in a sealed package.There is a brown spot by the green cap.There is only one occurrence so far.This was not used on any patient.Rcc received a complaint via phone.Customer states that they have a contaminated needle in a sealed package.There is a brown spot by the green cap.There is only one occurrence so far.Customer has product to return if needed and a picture is attached.This was not used on any patient.Ref number: 305764.Lot number: 4147142.
Additional Manufacturer Narrative
The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed brown foreign matter on the 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 were reviewed, and this batch meets our manufacturing specification requirements.The cause of the brown foreign matter contamination is attributed to sludge build-up resulting from fumes within the oven.Over time, this sludge accumulated on the inner oven surface and eventually dripped onto the eclipse hub surface.The oven fumes are extracted via an exhaust pipe.The exhaust pipe, along with the oven enclosure, was newly replaced in march 2025, and the current pipe has been verified to have no leakages.However, the assembled needle batch was produced in june 2024, prior to the installation of the new exhaust pipe and oven enclosure.

• Brand Name: BD NEEDLE ECLIPSE 21X1 RB TW
• 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21566574
• Report Number: 2243072-2025-00237
• Device Sequence Number: 4375331
• Product Code: FMI
• UDI-Device Identifier: 00382903057641
• UDI-Public: (01)00382903057641(11)240611(17)290531(10)4147142
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/17/2025

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: 305764
• Device Lot Number: 4147142
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown