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

Catalog Number	305759
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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 by customer that the bd eclipse 5/8" inch needle at base of needle has what appears to be paint on it.Rcc received a complaint via email.Incident or problem information date of incident (yyyy-mm-dd): (b)(6) 2026 type of incident/problem: a1.Defect (observed prior to use) level of harm: no effect - did not reach patient/person -- detected before use or does not touch patient during use incident details: bd eclipse 5/8" inch needle at base of needle has what appears to be paint on it unexpected or prolonged care? no frequency of problem: unknown other device/incident factors: invasive procedure? no there was no serious harm reported.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 representative samples submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the samples.Analysis of the samples showed no foreign matter on the returned samples.It is suspected that the user is referring to the epoxy trailing.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.Epoxy is used in the needle assembly process.The primary function of the epoxy is to bond the cannula firmly into the needle hub.A small amount of epoxy trailing can naturally occur during application.There is visual inspection in place to ensure that any epoxy trailing remains within the allowable limit, as defined in the process requirements.

• 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; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24314948
• Report Number: 2243072-2026-00096
• Device Sequence Number: 4875680
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)250402(17)300331(10)5084610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/13/2026

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: 305759
• Device Lot Number: 5084610
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown