MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305761
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
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 25x1 rb safety mechanism failed it was reported by customer that the needle safety is popping off instead of flipping over the needle.Rcc received a complaint via email.I received notice that we are having issues with the below item.The needle safety is popping off instead of flipping over the needle ¿ as designed.This has occurred specifically with the below lot number.The department is pulling the involved lot ¿ as we are concerned of needle sticks.Bd eclipse needle 25gx1¿ ¿ lot # 4237565 exp: 8/31/2029 mfg date: 9/1/2024.
Additional Manufacturer Narrative
Our quality engineer inspected the 33 representative samples submitted for evaluation.The reported issue of safety mechanism failure was not confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.Samples were subjected to a safety shield inspection to check for hub hook breakage with no abnormalities observed.Samples were subjected to an activation/ locking force test and samples were within specification.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.

• Brand Name: BD NEEDLE ECLIPSE 25X1 RB
• 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: 22215819
• Report Number: 2243072-2025-00756
• Device Sequence Number: 8659875
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610(11)240909(17)290831(10)4237565
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• 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: 305761
• Device Lot Number: 4237565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown