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

Catalog Number	305761
Medical Device Problem Codes	Mechanical Problem (1384); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 25x1 rb safety mechanism failed.It was reported by customer that needlestick occurred due to safety device coming off of needle after safety was activated on a hard surface and not using one handed method.Verbatim: rcc received a complaint via email.I was asked to pass along a safety issue that was reported by xxxxxx cc'd in this email.Please see details of the report below: ¿needlestick occurred due to safety device coming off of needle after safety was activated on a hard surface and not using one handed method.Entered into enterprise already and reported on tier 3 with investigation.Adding for xxxx alert investigation/tracking.¿ product: bd eclipse im needle.25 g 1 inch needle, 3056761 lot: 4338358 date of incident: (b)(6) 2025 location: xxxxxx.Additional information: no sample available patient impact: the impact was to an employee, and they unfortunately had a needlestick.We did discover that they activated the needle safety on a hard surface instead of one handed like they are supposed to.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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.

• 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: 23888896
• Report Number: 2243072-2025-01542
• Device Sequence Number: 4671506
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: (01)00382903057610(10)4338358
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/07/2026

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: 4338358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown