MAUDE Adverse Event Report: BECTON DICKINSON ECLIPSE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305759
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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 25x5/8 safety shield broke off it was reported by customer that saftey slipped off orange connector when staff attempted to apply it.Rcc received a complaint via email.Saftey slipped off orange connector when staff attempted to apply it.I submitted the uo and the number is 25-6433 xxxxx had an issue with a needle that when she went to apply the safety, it broke off.She does have the safety piece if we need to send it in, the needle was discarded.Please let me know if you need any further information! thanks! i am assuming this is on one of the new xx eclipse needles can you fill out a defective product form by chance? see attached.Please send me a copy of it once it has been completed for my tracking purposes.I am including xxxxxxxxx from xx to see if she can assist with reporting this to the company.
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 at molding process, there is a visual inspection on broken cannula catch/cannula lock pin at the safety shield molding in-process inspection and fail hook id inspection at the eclipse hub molding in-process inspection.Current control at the assembly process, there is functional test on activation/locking force test, deactivation/unlocking force test and eclipse safety shield inspection.Also, there is visual inspection of broken pivot pin at safety shield at the packaging in-process inspection.

• Brand Name: ECLIPSE
• 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: 22358929
• Report Number: 2243072-2025-00808
• Device Sequence Number: 18124008
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)240802(17)290731(10)4206639
• 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): 07/24/2025

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: 305759
• Device Lot Number: 4206639
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown