MAUDE Adverse Event Report: BECTON DICKINSON, S.A. NEEDLE 23X1-1/4 ECLIPSE SMARTSLIP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305886
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.
Event or Problem Description
It was reported that a needle 23x1-1/4 eclipse smartslip had the safety mechanism difficult to engage during use.The following was reported by the initial reporter: "smartslip hinders their view and they have had needle injury activating safety mechanism with index finger.".

• Brand Name: NEEDLE 23X1-1/4 ECLIPSE SMARTSLIP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 11610963
• Report Number: 3002682307-2021-00119
• Device Sequence Number: 11816177
• Product Code: FMI
• UDI-Device Identifier: 50382903058865
• UDI-Public: 50382903058865
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305886
• Device Catalogue Number: 305886
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention