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

Catalog Number	305891
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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
The cannula rotates when placing it on the intended syringe.In other words, between cannula and syringe there is no stable compound, so that active ingredients run wrong during administration.The defect was reported to us by our customer on 12.11.2025.No patient was harmed.Response received on:12/18/2025 the defect was first reported to us by our customer on november 12, 2025.The customer wrote: we are currently experiencing frequent problems with the eclipse needle 25g.The needle spins when attached to the syringe.There is no stable connection between the needle and the syringe, so the medication would leak out during administration.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305891 and lot number 2507005.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, sixty-seven (67) unused needle samples were received for evaluation by our quality team.The samples were assembled with a 5ml bd discardit syringe.The tested samples did not show any indication of leakage or failure in connection.Based on the investigation results, a cause related to the needle manufacturing process could not be determined at this time.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 use should ¿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 recur, we would appreciate the opportunity to evaluate the syringe sample involved.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: 23914191
• Report Number: 3002682307-2025-00151
• Device Sequence Number: 9148170
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: (01)00382903058914(11)250709(17)300630(10)2507005
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare 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: 305891
• Device Lot Number: 2507005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown