MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305762
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device expiration date: unknown.The reported lot# 9267472 was not found for the catalog number.Device manufacture date: unknown.Investigation summary: no photo/ sample were returned for investigation.Root cause could not be determined.The complaint will be re-opened and re-investigated if the sample is returned.Investigation conclusion: unable to confirm the customer experience as no photo/ sample was returned for investigation.Root cause description: no photo/ sample were returned for investigation.Root cause could not be determined.
Event or Problem Description
It was reported that a safety mechanism failure occurred during use with a needle eclipse 23x1 rb.The following information was provided by the initial reporter, "the safety guard on the needle had broken when the nurse attempted to push the safety guard down over the needle, resulting in the stick.The plastic of the safety guard broke at the base of the needle where the guard hinges with the needle." no medical intervention was reported.

• Brand Name: NEEDLE ECLIPSE 23X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9861834
• Report Number: 8041187-2020-00158
• Device Sequence Number: 3307894
• Product Code: FMI
• UDI-Device Identifier: 30382903057628
• UDI-Public: 30382903057628
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/03/2020

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: 305762
• Device Catalogue Number: 305762
• Device Lot Number: SEE. H.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/20/2020
• 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