MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305764
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: not applicable as no sample is returned.Investigation conclusion: unable to confirm the customer experience as actual sample was not returned.Root cause description: eclipse usage guidelines have been provided where in the guidelines stated ¿activation of the protective mechanism may cause minimal splatter of any fluid that is remaining in the needle after injection¿.Root cause is therefore not established.Rationale: eclipse usage guidelines been provided.
Event or Problem Description
It was reported that needle eclipse 21x1 rb tw leaked.This was discovered during use.The following information was provided by the initial reporter: material no: 305764, batch no.: unknown.It was reported that as the safety device is engaged, blood will either dribble out of the needle tip or on some occasions, it will almost splash out a drop.Verbatim: the other day it was brought to my attention that we have had some issues with the use of the eclipse safety needles.No one has ever said anything until now and it may be a user error issue, but i wanted to follow-up on it.It seems that as the safety device is engaged, that it is not uncommon that blood will either dribble out of the needle tip or on some occasions it will almost splash out a drop.We have not had any situations in which someone has been harmed or even exposed.I am understanding that this has been happening for a long time, so it leads me to believe it's not specific to a lot number, but most likely is related to the guidelines warning of excess blood in the needle.

• Brand Name: NEEDLE ECLIPSE 21X1 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9701217
• Report Number: 8041187-2020-00076
• Device Sequence Number: 654246
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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 Model Number: 305764
• Device Catalogue Number: 305764
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/12/2020
• 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: Other