MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 30X1/2; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305757
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 30x1/2 safety shield broke off.It was reported by customer that when nurse using item: bf305757 to give a patient a shot.After injection, she went to flip the safety up and it fell off, resulting in a needle stick injury to the staff member.Rcc received a complaint via email.Customer reference: (b)(4), cardinal po: (b)(4), item: 305757, customer po: (b)(4), lot#: 4159792.Case intake form submitted thru cardinal: (b)(4).Description as reported: per nursing staff, on (b)(6) 2025, she was using item: bf305757 to give a patient a shot.After injection, she went to flip the safety up and it fell off, resulting in a needle stick injury to the staff member.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
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 numbers 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.Current control there is a visual inspection on broken cannula catch/cannula lock pin at the safety shield molding in-process inspection, fail hook id inspection at the eclipse hub molding in-process inspection, activation/locking force functional test, deactivation/unlocking forces functional test and eclipse safety shield inspection at the outgoing inspection.Visual inspection of damage pivot pin at the packaging in-process inspection.

• Brand Name: BD NEEDLE ECLIPSE 30X1/2
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21537129
• Report Number: 2243072-2025-00218
• Device Sequence Number: 7642668
• Product Code: FMI
• UDI-Device Identifier: 00382903057573
• UDI-Public: (01)00382903057573(11)240611(17)290531(10)4159792
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305757
• Device Lot Number: 4159792
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown