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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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
This mdr is the result of additional information and sample received from the customer.Based on the follow up response it was reported that "i hereby confirm that between (b)(6) and (b)(6) 2025 problems occurred with the cannulas." original report: it was reported that "it is with great frustration that i have to inform you that in our team of 20 doctors we have now had to discard several vaccines; at least 6 influenza vaccines and 3 hepatitis b vaccines - because the bd cannulas did not connect correctly with the vaccination syringes.The vaccine leaked sideways and therefore had to be disposed of!" we would like to ask you to cover the costs of the affected vaccines and to inform us which lots, in addition to the one shown in the attached picture, are also affected and must be discarded.When did the incident occur? before use.

• 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: 24483356
• Report Number: 3002682307-2026-00011
• Device Sequence Number: 10676051
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(11)250910(17)300831(10)2509006
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: 2509006
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown