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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
When writing the cannula onto the syringe with luer-lock, the cannula turns slightly over.A firm connection cannot be made.Leakage occurs during the application of the vaccines.Can also be over-twisted relatively quickly when they are connected to the syringes.On (b)(6).The fact that other cannulas from other lots are also relatively easy to overtighten is a customer feedback.These customers vaccinate between approximately 30 and 80 people daily.They have been doing this for many years and have never had any problems with overtightening.Now they are using our bd eclipse and are experiencing problems.This is based on general feedback.There is no information available regarding other lots.No (was patient or a user harmed?).
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, both used and unused samples were received.The samples for reference lot 2507006 were also accompanied by a syringe used with a luer lock connection.We have also observed that some of the used needles presented damage in the hub, that might have been done during use.The snap clip (plastic white part inside the hub) was observed not activated, which is crucial to assure a proper connection.The unused needle samples were assembled with the syringe provided and no issues of leakage or failure in connection were noticed.Based on the investigation results, a cause related to the needle manufacturing process could not be determined for this incident.Engagement force is measured prior to the final release of each lot produced and the test results for this lot were found to be 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 (the most common syringe design in europe).We recommend following the instructions for use, which are unique in recommending the user ¿push firmly when attaching the needle to the syringe.¿ and the user should be sure the clip is activated.When attaching the needle to a luer lock connection, a stronger resistance may be felt, this is not preventing a connection from being made.The user should ¿push while twisting¿ however, if the movement is inadvertently paused and the twisting/ turning occurs later, the needle will disengage.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: 23953877
• Report Number: 3002682307-2025-00154
• Device Sequence Number: 10591219
• 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: GM
• 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): 03/11/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/04/2026
• Supplement Report FDA Received Date: 03/16/2026
• 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