MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD ECLIPSE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305712
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and il was used.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 the bd needle eclipse 18x1-1/2 rb had foreign matter.The following information was provided by the initial reporter: material # 305712.Batch # 5294410.Verbatim: i¿m not sure if this is in you portfolio.See photos, image (b)(6) looks like the needle is painted, it¿s not that¿s a shadow.There is some material stuck to the needle mid-way.Lot number is in the other photo.The item was placed in the sharps container, so no way to get that out.
Additional Manufacturer Narrative
An analysis of the device history record (dhr) was performed, and quality notifications were reviewed.No records potentially related to this defect were identified.Regarding the foreign material defect, the provided photo was evaluated, and it was possible to confirm the reported incident.During this evaluation, the presence of contamination on the cannula was observed, originating from the assembly processes.Bd confirms and reproduces the complaint.No maintenance orders or quality notifications related to this incident were found.However, contamination was identified on the needle; nevertheless, it was not possible to determine the nature of the contamination or the root cause of its occurrence.Bd confirms the complaint.The manufacturing process includes a quantitative inspection routine aimed at maintaining a statistical basis for material release.These materials undergo visual and functional tests intended to prevent potential defects from being delivered to the market.No defects were identified during the production of the evaluated lot.As this process requires operational attention, associates will be notified through note no.21250127.As this is the first complaint registered for the lot and does not exceed the acceptable quality notification (nqa) limit, the incident identified from this complaint will be monitored for trend evaluation.
Event or Problem Description
No additional information provided.

• Brand Name: BD ECLIPSE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24698210
• Report Number: 3003916417-2026-00052
• Device Sequence Number: 10439644
• Product Code: FMI
• UDI-Device Identifier: 00382903057122
• UDI-Public: (01)00382903057122(11)251021(17)300930(10)5294410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: Other
• Device Catalogue Number: 305712
• Device Lot Number: 5294410
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown