MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 23X1-1/4 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305769
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Information (3190)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device lot #: the customer provided lot # 0183873.This does not match the catalog number provided.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that needle eclipse 23x1-1/4 rb had a safety mechanism failure.The following information was provided by the initial reporter: safety didnt engage properly.Needlestick injury caused by the safety not engaging properly.
Event or Problem Description
It was reported that needle eclipse 23x1-1/4 rb had a safety mechanism failure.The following information was provided by the initial reporter: safety didnt engage properly.Needlestick injury caused by the safety not engaging properly.
Additional Manufacturer Narrative
H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.

• Brand Name: NEEDLE ECLIPSE 23X1-1/4 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11336184
• Report Number: 8041187-2021-00100
• Device Sequence Number: 13658997
• Product Code: FMI
• UDI-Device Identifier: 00382903057696
• UDI-Public: 00382903057696
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161170
• 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): 04/12/2021

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 Catalogue Number: 305769
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/19/2021
• 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