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

Catalog Number	305892
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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 attaching to the glass cone is difficult and causes the attached luer lock cone to pop off the glass syringe the samples are attached.When did the incident occur? during use.Short description on the glass syringe of the vaccines, the luer lock hub fitted by the syringe manufacturer comes loose when the syringe is screwed on.Additional information provided: was the device being used in/on patient when the issue occurred? during and after use was patient or user harmed? if yes, please explain no one would be harmed could you please confirm whether the sample is ready for collection? the samples are being sent to heidelberg.

• 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: 24642826
• Report Number: 3002682307-2026-00025
• Device Sequence Number: 18693942
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(11)250203(17)300131(10)2502007
• 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): 05/08/2026

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: 2502007
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown