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	02/04/2026
Type of Reportable Event	Malfunction
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 complaint received from customer capio vc applies to item 305892 with lot 2509006.The reason is it comes loose and cannot be screwed onto the sprayer.There are no needles included with this vaccination syringe and they have been instructed to buy this needle for this purpose.In connection with the administration of the influenza vaccination, vaccine fluid has leaked onto the patient¿s arm.The leakage is located between the needle and the syringe.We have experienced reduced quality of the plastic/connection of the vaccination syringe, as during preparation we had to discard many needles that could not be ¿screwed¿ on properly.Lots 2103011 2509006.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305892 and lot number 2103011.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) physical sample from lot 2509006 was received for evaluation by our quality team.The sample was assembled with a bd 5ml discardit syringe and no signs of connectivity failure or leakage were observed.Based on the investigation results, a cause related to the needle manufacturing process could not be determined.Final testing is completed prior to the release of every lot produced and we can confirm that the final engagement force tests were within specification for these lots.Smarslip technology ¿ has been introduced to ensure a secure connection is made with luer slip syringes, which are the most common design (in europe).In accordance, we recommend following the instructions for use, which recommend the user ¿push firmly when attaching the needle to the syringe.¿ and the user should be sure the clip is activated.When attaching a needle with smartslip technology (tm) to luer lock connection, the clinician may feel a stronger resistance, this is not preventing a connection from being made, the user should ¿push while twisting.¿ if this issue were to reoccur, we would appreciate the opportunity to review the affected needle and syringe sample(s) involved.Based on the preventive measures in place, we believe the probability of this defect is very low with an unlikely chance of recurrence.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: 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: 24373054
• Report Number: 3002682307-2026-00005
• Device Sequence Number: 11997346
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(11)210322(17)260228(10)2103011
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 305892
• Device Lot Number: 2103011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown