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

Catalog Number	305886
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the 23 g x 1-1/4 in.Eclipse needle smartslip experienced leakage.The following information was provided by the initial reporter: needle breaking the leur lock component of the vaccine syringe when attached.There have also been reports of vaccine leakage around the needle.
Event or Problem Description
It was reported that the 23 g x 1-1/4 in.Eclipse needle smartslip experienced leakage.The following information was provided by the initial reporter: needle breaking the leur lock component of the vaccine syringe when attached.There have also been reports of vaccine leakage around the needle.
Additional Manufacturer Narrative
H.6.Investigation: bd has been provided with samples for 305886 lot 1709010 to investigate for this record.1 used sample was returned disengaged from a syringe but with the luer-lock accessory and 1 opened with an empty blister.Visual inspection revealed no defects or damage to either samples.As a result, bd was unable to verify the reported issue.Returned samples were attached to a reference syringe and no issues were observed when attaching.No leakage was noticed during this demonstration.The device history report review reveals no issues or abnormalities related to the manufacturing process.

• Brand Name: 23 G X 1-1/4 IN. ECLIPSE NEEDLE SMARTSLIP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8616662
• Report Number: 3002682307-2019-00310
• Device Sequence Number: 380837
• Product Code: FMI
• UDI-Device Identifier: 00382903058860
• UDI-Public: 00382903058860
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 305886
• Device Lot Number: 1709010
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: Other