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

Catalog Number	305888
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced blood exposure/splash.It has not been specified whether medical intervention was applied as a result.The following information was provided by the initial reporter: the client informs us that a nurse has had an accident exposure to blood with the following product: bd eclipse ref 305888, lot 1805008.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced blood exposure/splash.It has not been specified whether medical intervention was applied as a result.The following information was provided by the initial reporter: the client informs us that a nurse has had an accident exposure to blood with the following product: bd eclipse ref (b)(4), lot 1805008.
Additional Manufacturer Narrative
Investigation summary: a device history record review was completed for provided lot number 1805008.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples of the same lot number were obtained from the manufacturing facility for further evaluation.The retained needles were assembled with a bd emerald syringe.The connections made between the needle and the syringe were per specification with no signs of leakage observed.The bd eclipse needle is compatible with syringes that have a conical tip, otherwise known as luer slip tip.The smartslip¿ technology has been introduced to help ensure a secure connection is made with luer slip syringes.It has been designed to reduce the risk of needle disengagement from these syringe types.Smartslip technology is compatible with both luer slip and luer lock connections.It is recommended that the instructions for use are closely followed when using the eclipse needle and that the needle is firmly pushed and the clip is verified as activated.If a strong resistance is felt, a push while twisting method may be used.

• Brand Name: BD ECLIPSE NEEDLE
• 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: 11256406
• Report Number: 3002682307-2021-00029
• Device Sequence Number: 3256134
• Product Code: FMI
• UDI-Device Identifier: 00382903058884
• UDI-Public: 00382903058884
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 305888
• Device Lot Number: 1805008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 01/31/2021
• Supplement Report FDA Received Date: 04/05/2021
• 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: Other