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

Catalog Number	305767
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that needle broke during use.Complaint via email.We were notified of a complaint from a customer stating needle broke during use.Please see the below details regarding the reported issue.If it is indicated that a sample is available, please provide shipping instructions within 30 days or the sample will be disposed of.Medline complaint#: (b)(4), defect description: needle broke at the base during use, medline part #: 32351 product description: ndl safety 25gx1.5 eclipse vendor part#: 305767, lot#: 5199737, date reported: 2/25/2026, sample received: no, response needed: yes, incident reported to the fda as mdr-30 day.Reference no.1423395-2026-00052, please reference the above complaint number in all future communications.If you have questions or need additional information, please reach out to (b)(6).
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: 24847818
• Report Number: 2243072-2026-00272
• Device Sequence Number: 8926541
• Product Code: FMI
• UDI-Device Identifier: 00382903057672
• UDI-Public: (01)00382903057672(10)5199737
• 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: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 305767
• Device Lot Number: 5199737
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown