MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE SMARTSLIP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305894
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle eclipse s/t 21x1 rb tw needle hub was cracked / damaged.The following information was provided by the initial reporter: when loading propofol with a green bd eclipse needle, batch 2505002, 0.8x 25mm, a green particle comes off and remains inside the syringe.The particle is visible and the medication is not used.Attached is a photo of what happened, where you can see the particle indicated by the customer.When did the incident occur? before use.
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
A device history record review was completed for provided material number 305894 and lot number 2505002.The review did not reveal any abnormalities detected during the production process that could have contributed to the reported defect, and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, a green plastic particle was observed in the syringe liquid.However, through the picture sample alone, we cannot observe if a part of the needle hub component is missing or confirm if the hub component cracked.Based on the information available from the picture sample provided, we cannot conclusively determine that the green particle is a component originating from the eclipse needle hub.If it were, it would have had to be located inside the hub prior to assembly with the syringe cone and introduced at the moment of engagement.The likelihood that a particle of that exact size could remain lodged in that position and subsequently enter the syringe is extremely isolated.We have no record of similar complaints.In the absence of the physical sample and without the ability to reproduce the scenario described, we will review our manufacturing process to identify or rule out any potential root cause and take appropriate action if necessary.We apologize for any inconvenience this situation may have caused.If you were to experience any future issues, we would appreciate the opportunity to review the affected sample(s) for a deeper analysis.
Event or Problem Description
No additional information.

• Brand Name: BD ECLIPSE SMARTSLIP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24376500
• Report Number: 3002682307-2026-00007
• Device Sequence Number: 14845804
• Product Code: FMI
• UDI-Device Identifier: 00382903058945
• UDI-Public: (01)00382903058945(11)250430(17)300430(10)2505002
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 305894
• Device Lot Number: 2505002
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown