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

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	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle eclipse s/t 23x1 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: it was reported that, difficult to insert threads at an angle, leakage additional information provided: no - patient/ user was not harmed.Date of event: 2026-02-19.
Additional Manufacturer Narrative
Investigation summary: as no sample or picture has been provided by the customer and considering the fact that the dhr investigation and the retain sample examination didn¿t show any abnormality we could not identify any possible root cause related to the needle manufacturing process at this time.In addition, we confirm that all results for engagement force that is measured as a final test prior to the release of any batch of product to the market were found within the 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).Moreover, our needles are manufactured and released according to applicable procedures and specifications and complies with international standard 80369-7 "conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment¿.
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: 24457459
• Report Number: 3002682307-2026-00010
• Device Sequence Number: 15944884
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(11)251031(17)301031(10)2511002
• 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): 04/15/2026

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: 2511002
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown