MAUDE Adverse Event Report: BECTON DICKINSON, S.A. ECLIPSE SMARTSLIP; NEEDLES, HYPODERMIC

Catalog Number	305892
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, there is a leakage of vaccine because the needle cannot be assembled correctly.I suspect that it is the blue plastic piece that is causing the problem.On (b)(6) 2025 vaccine leaked between the needle and syringe when the needle could not be inserted correctly, which meant that the patient did not receive the full dose.It's difficult to estimate, but we have vaccinated about 1,500 people and one of the nurses says there may be 1-2 on each row of needles.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305892 and lot number 2509006.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, eight (8) used needle samples were received for evaluation by our quality team.The needle samples were assembled with a bd emerald 10ml syringe and no issues of leakage or connectivity failure were noticed.Based on the investigation results, a cause related to the needle manufacturing process could not be determined at this time.Engagement force is tested as a final test prior to the release of each lot produced, and this lot was found to be released within specifications.Smartslip technology ¿ has been introduced to help ensure a secure connection is made with luer slip syringes.It has been designed to reduce the risk of needle disengagement from luer slip syringes, which are the most common design (in europe).We recommend following the instructions for use which are unique in recommending that the user ¿push firmly when attaching the needle to the syringe.¿ the user should be sure the clip is activated.When attaching the needle to a luer lock connection, the clinician may feel a stronger resistance.This is not preventing a connection from being made.The user may ¿¿push while twisting;¿ however, if the movement is inadvertently paused and the twisting/ turning occurs later, the needle will disengage.If this issue were to reoccur, we would appreciate the opportunity to review the syringe used.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: ECLIPSE SMARTSLIP
• Common Device Name: NEEDLES, HYPODERMIC
• 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: 23795773
• Report Number: 3002682307-2025-00140
• Device Sequence Number: 10453345
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(11)250910(17)300831(10)2509006
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 305892
• Device Lot Number: 2509006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown