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

Catalog Number	305894
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ needle eclipse smartslip hub is perforated and allowed blood to leak.This was discovered during use.No date/time or patient information was given.The following information was provided by the initial reporter: the hub of the needle is perforated and there were a blood leakage.
Additional Manufacturer Narrative
H.6.Investigation summary: bd has reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Bd was not provided with photos or samples for catalog 305894 lot 1811008 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.
Event or Problem Description
It was reported that bd¿ needle eclipse smartslip hub is perforated and allowed blood to leak.This was discovered during use.No date/time or patient information was given.The following information was provided by the initial reporter: the hub of the needle is perforated and there were a blood leakage.

• Brand Name: BD¿ NEEDLE ECLIPSE SMARTSLIP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8755469
• Report Number: 3002682307-2019-00389
• Device Sequence Number: 2280487
• Product Code: FMI
• UDI-Device Identifier: 00382903058945
• UDI-Public: 00382903058945
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/17/2019

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: 10/31/2023
• Device Catalogue Number: 305894
• Device Lot Number: 1811008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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