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

Catalog Number	305762
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).  fda notified: the initial reporter also notified the fda on 11/05/2019 via medwatch # mw5090690.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a needle stick occurred during use with a needle eclipse 23x1 rb.The following information was provided by the initial reporter, "it was reported the staff member was giving a hep a vaccine with an im needle and stuck her l thumb when closing the safety lok.Staff giving hep a vaccine with im needle, stuck l thumb with closing safety lok.Sent to contracted medical provider for appropriate f/u care.Fda safety report.".
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that a needle stick occurred during use with a needle eclipse 23x1 rb.The following information was provided by the initial reporter, "it was reported the staff member was giving a hep a vaccine with an im needle and stuck her l thumb when closing the safety lok.Staff giving hep a vaccine with im needle, stuck l thumb with closing safety lok.Sent to contracted medical provider for appropriate f/u care.Fda safety report.".

• 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: 9386848
• Report Number: 8041187-2019-00962
• Device Sequence Number: 16699180
• Product Code: FMI
• UDI-Device Identifier: 30382903057628
• UDI-Public: 30382903057628
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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?: No
• Operator of Device: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 305762
• Device Lot Number: 8020464
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: Required Intervention