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

Catalog Number	305892
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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 attachment came loose when the needle was screwed into place.It was possible to reattach the attachment to the vaccine, but it came loose every time the needle was screwed in, so it could also be due to the needles.It felt like there was "air pressure" in the syringe that pushed up both the attachment and the needle.Injecting the vaccine into the left arm, i notice that the dose ends up to the side, drops on the arm.Ran where the needle is screwed in.Unclear how much of the dose went in.During vaccination 12/12 when leakage occurred during vaccination and part of the dose ran alongside.Where part of the dose ran next to the pupil means a new vaccination.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305892 and lot number 2501003.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, two (2) unused needle samples, one (1) used needle sample, and a syringe sample were received for evaluation by our quality team for this record and for related record (b)(6).Using the syringe provided, one of the unused needles was used.Proper activation of the snap clip was confirmed and no indications of leakage or connectivity failure were observed.The needle bevel was found to show no signs of defect.Based on the investigation results, a cause related to the needle manufacturing process could not be determined.Engagement force is measured as a final test prior to the release of every lot, and the results were found to be within specifications for lot 2501003.Smartslip technology ¿ has been introduced to help ensure a secure connection is made with luer slip syringes (the most common syringe design in europe).We recommend the user follow 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 a needle with smartslip technology (tm) to a 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¿.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: 23995161
• Report Number: 3002682307-2025-00157
• Device Sequence Number: 13389263
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(11)250107(17)291231(10)2501003
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 2501003
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown