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

Catalog Number	305760
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
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
Date of incident (yyyy-mm-dd): (b)(6) 2025.Ahs optional report to cmdsnet (health canada): incident details: attempted to attach the 5/8 bd eclipse needle to the mmrvar syringe and it was challenging to get the hub of the needle to secure onto the mmrvar syringe.In fact, the adjoining part of the mmrvar syringe started to come away from the syringe.When it did join it was crooked and wobbly.Showed same to cdn, she advised to attempt to try another needle.Same done and join and needle felt stable and secure.Primed needle no leakage noted.Then administered vaccine at which point vaccine was leaking out of the join area.Withdrew needle and reported to parent and cdn.Confirmed with cdn as to how to proceed, confirmed same with ipsm.Re administered mmrvar vaccine in the other limb.There was no serious harm reported.9/13 customer response.Yes.The dose needed to be repeated in the other limb, no reported adverse events to the nurse or the patient.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305760 and lot number 2011007.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 was returned for evaluation by our quality team.The sample shipment contained a used eclipse needle assembled with a vaccine with a luer lock connection.The snap clip was not activated, which is crucial to assure the proper connection for the eclipse needle.Moreover, a luer lock connection was used when the eclipse needle is recommended to be used with a luer slip connection.As a result, the handling of the product itself needs to be considered as part of the cause for this reported incident.As the needle was used and full of crystalized medicine, it was not possible to reproduce the assembly with the eclipse needle and the vaccine.Through the sample investigation, it was not possible to reproduce the reported defect nor was a manufacturing related defect observed.Based on the investigation results, a cause related to the manufacturing process cannot be determined.We confirm that all results for engagement force measured as part of the final testing prior to lot release 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).In accordance, we recommend following the ifus for bd eclipse smartslip which are unique in recommending a "push firmly when attaching the needle to the syringe." the use should be sure ¿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 to be made.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: 23101658
• Report Number: 3002682307-2025-00112
• Device Sequence Number: 18478348
• Product Code: FMI
• UDI-Device Identifier: 00382903057603
• UDI-Public: (01)00382903057603(11)201104(17)251031(10)2011007
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 10/31/2025
• Device Catalogue Number: 305760
• Device Lot Number: 2011007
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown