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

Catalog Number	305891
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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
There is a ring in the cannula attachment, which can only be pressed in by force on some cannulas and can be properly connected to the syringe cone.
Event or Problem Description
08-december-2025: please indicate the date of the incident.- at the second location in (b)(6), the incident took place again on (b)(6).Could you please confirm the amount affected by this reported defect? - about 5 cannulas were affected on this one! could you please confirm if this cannula broke off during use by the patient? - no.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305891 and lot number 2502004.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) picture was received for evaluation.However, the picture only showed the product information label, not the device itself.Based on the picture sample, no defects related to the needle product could be detected.Twenty (20) retained samples of the reported lot number were obtained from the manufacturing facility for further review.The retained samples were assembled with a 10ml discardit syringe and no signs of connectivity issues were found.Based on the investigation results, a cause related to the needle manufacturing process could not be determined for this incident.Judging by the description ¿there is a ring in the cannula connector, which, in some cannulas, can only be pressed in with force and properly connected to the syringe cone,¿ this is believed to reference to the snap clip which is the plastic white part positioned inside the hub.This part needs to be pushed to ensure the correct connection between the needle and the syringe.Based on the feedback shared, we cannot discard the possibility that handling may have played a role in this reported incident.

• 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: 23870666
• Report Number: 3002682307-2025-00146
• Device Sequence Number: 14788415
• Product Code: FMI
• UDI-Device Identifier: 00382903058914
• UDI-Public: (01)00382903058914(11)250203(17)300131(10)2502004
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 305891
• Device Lot Number: 2502004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/22/2026
• 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