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

Catalog Number	305892
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
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.Engagement force is measured as a final test prior to the release of each lot produced, and all results were found to be within specification for this lot.To aid in the investigation of this issue, two (2) unused needle samples and one (1) used needle sample were received for evaluation by our quality team.The needle samples were tested with the syringe provided.Proper activation of the snap clip was confirmed, and no indications of connectivity issues or leakage were observed.The needle bevels were examined, and no signs of dullness were found.Based on the investigation results, a cause related to the needle manufacturing process could not be determined for this incident.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 instructions for use for the bd eclipse smartslip, which are unique in recommending the user "push firmly when attaching the needle to the syringe." and to be sure that 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 to be made, the user should then ¿push while twisting.¿ if the movement is inadvertently paused and the twisting/ turning occurs later, the needle will disengage.For the issue of needle blunt, we would like to inform you that the assembly process has an inline camera system which inspects all needle tips, automatically rejecting any defective units identified.Thanks to our preventive measures and rigorous sampling inspections, we are confident that the likelihood of this type of non-conformance occurring in our process is extremely low and limited to exceptional cases.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
It was reported that the bd needle eclipse s/t 23x1 rb had leakage at the luer connection.The following information was provided by the initial reporter: verbatim: ¿ it was reported that discarded 3 triaxis vaccines with batch number: x3c40d1 when the attachment came loose when the needle was screwed into place.The exact same thing happened with all three vaccines.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.Lot number on the needles: 2501003.Then, during monday's vaccination a blunt needle was discovered, which also had to be discarded, with the same lot number 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 use.

• 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: 24932224
• Report Number: 3002682307-2026-00047
• Device Sequence Number: 16120043
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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 Catalogue Number: 305892
• Device Lot Number: 2501003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 04/20/2026
• 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