MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD Eclipse SmartSlip; Needle, hypodermic, single lumen

Catalog Number	305895
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: there have been incidents it was reported that a customer cancelled this order and disposed of part of it due to.¿however, eclipse needles are being supplied, and these have been rejected within the eu due to the risk of pricking.¿ they have also experienced the following: we have had incidents with these needles where colleagues, whilst securing the needle, have slipped their thumb over the pink safety guard and, as a result, ended up with their thumb inside the needle.I would like to clear this up; to my knowledge, the product simply complies with eu requirements.Could you please provide a little more clarification on this so that we can pass this information on to the customer?.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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 ; +1(847)393-5694
• MDR Report Key: 50817556
• Report Number: 3002682307-2026-00191
• Device Sequence Number: 16121654
• Product Code: FMI
• UDI-Device Identifier: 00382903058952
• UDI-Public: (01)00382903058952
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 305895
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown