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

Catalog Number	305762
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation conclusion: the complaint is unconfirmed as no photo / samples received.Root cause description: a review of past 12 months quality notification were performed and no quality notification was raised on the reported defect.The reported defect cannot be confirmed as no photos / samples were returned for evaluation.Therefore, root cause could not be determined.The complaint will be re-opened and re-investigated if the sample is returned.Rationale: photos and/or samples were not returned for investigation.The complaint will continue to be tracked and monitored.
Event or Problem Description
It was reported that the needle eclipse 23x1 rb experienced a safety failure that would not engage.The following information was provided by the initial reporter: when the nurse used her thumb to engage the safety mechanism, it would not close over the needle and felt like it hadn't luer-locked onto the vial properly to begin with.Felt flimsy & would not engage.

• 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: 8664712
• Report Number: 8041187-2019-00422
• Device Sequence Number: 11339937
• Product Code: FMI
• UDI-Device Identifier: 30382903057628
• UDI-Public: 30382903057628
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161170
• 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
• Report Date (Section B): 05/20/2019

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: 10/31/2023
• Device Catalogue Number: 305762
• Device Lot Number: 8302648
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/03/2019
• 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