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

Model Number	305889
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Anxiety (2328); Needle Stick/Puncture (2462)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 safety device on the bd eclipse¿ needle smartslip¿ failed after use, causing the needle to fall to the floor and the user to receive a dirty needle stick between the thumb and index finger.The user received a blood test as a result.The following information was provided by the initial reporter: "on thursday, september 3, i used a needle from your company on a patient, with smartslip, but the safety did not work, it came loose and fell to the floor and i got the needle stick in me.As a result, i have to test myself for blood contamination." "after have administered an injection on a patient, the complainant got a needle stick injury after the safety cover fell of while she was trying to cover the needle.The needle penetrated the skin between the thumb and index finger, and she started bleeding.This has caused both physical pain and psychological suffering.".
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was performed for provided lot number 1710010 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As samples were unavailable for return, twenty retained samples of the same lot number were obtained from the manufacturing facility for investigation by our quality engineer team.The retained samples were inspected with no defects identified and the safety mechanisms were able to be successfully activated by following the user guide.Each product lot is tested prior to release through a final shield activation test.This test measures the force required to activate the eclipse hypodermic safety needle product.All results were within specification for the release of this lot number.Based on the investigation results, a cause related to the manufacturing process could not be determined for this incident.
Event or Problem Description
It was reported that the safety device on the bd eclipse¿ needle smartslip¿ failed after use, causing the needle to fall to the floor and the user to receive a dirty needle stick between the thumb and index finger.The user received a blood test as a result.The following information was provided by the initial reporter: "on thursday, september 3, i used a needle from your company on a patient, with smartslip, but the safety did not work, it came loose and fell to the floor and i got the needle stick in me.As a result, i have to test myself for blood contamination." "after have administered an injection on a patient, the complainant got a needle stick injury after the safety cover fell of while she was trying to cover the needle.The needle penetrated the skin between the thumb and index finger, and she started bleeding.This has caused both physical pain and psychological suffering.".

• Brand Name: BD 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: 10610884
• Report Number: 3002682307-2020-00291
• Device Sequence Number: 19484120
• Product Code: FMI
• UDI-Device Identifier: 50382903058896
• UDI-Public: 50382903058896
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 11/13/2020

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: 09/30/2022
• Device Model Number: 305889
• Device Catalogue Number: 305889
• Device Lot Number: 1710010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/13/2020
• 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