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

Catalog Number	305892
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	Discomfort (2330)
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
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.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.Response received on:12/15/2025 1:59 pm could you please confirm the patient impact? created discomfort for the student who was to be vaccinated where the needle was blunt (the student was also afraid of injections) and had to stop to prepare a new dose.New situation (12/12) - where part of the dose ran next to the pupil means a new vaccination.
Additional Manufacturer Narrative
Correction: cancel mdr- event was captured in mfr report # 3002682307-2025-00157.
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: 23901558
• Report Number: 3002682307-2025-00147
• Device Sequence Number: 15981665
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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