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	10/23/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Failed connection between the bd hypak syringe and the bd eclipse needle with smartslip technology, 0.6x22mm, resulting in vaccine leakages or the hcp not able to connect the needle with the syringe luer lock.During vaccination there was a pressure and all parts came loose and some of the vaccine flowed down the student's arm in an unknown amount.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305892 and lot numbers 2310001 and 2407003.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.The picture shows a syringe with a luer lock connection and an eclipse needle.No indications of syringe needle connectivity issue or leakage could be observed through the picture alone.As the physical samples were not available, the reported defect could not be reproduced.Twenty (20) retained samples from the reported lot numbers (2310001 and 2407003) were obtained from the manufacturing facility for evaluation.The retained samples were assembled with a 10ml discardit syringe and no signs of connectivity issues were observed.Based on the investigation results, a cause related to the needle manufacturing process could not be determined.Engagement force is measured as a final test prior to the release of each lot produced, and we can confirm that all results for the reported lots were found to be within specifications.We would like to inform you that smartslip technology (tm) has been introduced to help to ensure that 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 syringe design (in europe).We recommend that the instructions for use are closely followed as they are unique in recommending the user "push firmly when attaching the needle to the syringe" and to be sure that the ¿clip¿ is activated.When attaching a needle with smartslip technology (tm) to a luer lock connection, the clinician may feel a stronger resistance; this is not preventing a connection from being made.The user should do a ¿push while twisting¿ method; however, if the movement is inadvertently paused and the twisting/turning occurs later, the needle will disengage.Moreover, our needles are manufactured and released according to applicable procedures and specifications and complies with international standard iso 594/1 "conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment.¿ 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.

• 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: 23551162
• Report Number: 3002682307-2025-00133
• Device Sequence Number: 9283626
• Product Code: FMI
• UDI-Device Identifier: 00382903057603
• UDI-Public: (01)00382903057603(10)2407003
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: 2407003
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown