MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD ECLIPSE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	305757
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
For the past several weeks, multiple staff members have noticed that the 30g x 1/2" needles with lot # 4206646 and expiration date of 7/31/2029 have been very difficult to press through multiple patient's skin while giving allergy shots.The needle will either bounce off the patient's skin or if it does press through, it is not smooth and it feels like you have to force it through the skin.We have never had this issue before with these needles.They usually glide through smoothly even if there is built up scar tissue from previous shots.We rotate the site of the shots each visit.Patients have been reporting increased pain when the needle manages to go through the skin.This is happening with about 50%-75% of the needles.There is no way for us to tell beforehand whether or not the needle is sharp unless we begin to press it through the patient's skin.

• Brand Name: BD ECLIPSE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 22991185
• Report Number: 22991185
• Device Sequence Number: 13128811
• Product Code: FMI
• UDI-Device Identifier: 00382903057573
• UDI-Public: (01)00382903057573
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2025
• Report Date (Section F): 07/25/2025

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 Model Number: 305757
• Device Catalogue Number: 305757
• Device Lot Number: 4206646
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2025