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

Catalog Number	305760
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
The following information was provided by the initial reporter: patient was administered azacitidine s.C.The needle started leaking at some point.Needle replaced; on inspection i saw a minimal tear.Risk to patient: medium notes: the complaint material was not retained.Therefore, this report is for your records only.Date of complaint: (b)(6) 2026.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: a complaint history review could not be performed as no batch/lot number was made available for this reported event.A dhr review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause couldn't be determined due to unavailability of sample/lot number information.
Event or Problem Description
Additional information provided by customer on 3/14/2026: the tear was noticed in the luer.No photos.The defective product has been thrown away; no lotnrs.Anymore.The device was used on the patient.Patient wasn¿t harmed.The hcp was present.The fluid was azacitidine (chemo).No additional medical intervention or medication was required.
Additional Manufacturer Narrative
(b)(4) follow up report for additional information.Annex a code was updated to a0404 - crack (1135).Annex e code was updated to e2403 - no clinical signs, symptoms or conditions.Annex f code was updated to f26 - no health consequences or impact.

• Brand Name: 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: 24571374
• Report Number: 3002682307-2026-00018
• Device Sequence Number: 12903687
• Product Code: FMI
• UDI-Device Identifier: 00382903057603
• UDI-Public: (01)00382903057603
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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: 305760
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/20/2026; Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/24/2026; 03/26/2026
• 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