MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ECLIPSE S/T 30X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305892
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
The cap broke loose when trying to close the safety device.No harm.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305892 and lot number 2411006.The review did not reveal any abnormalities detected during the production process that could have contributed to the reported defect, and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, a safety shield component was observed.From the picture itself it is not possible to determine damage/breakage to the safety shield component or to the connection point of the hub.Twenty (20) retained samples of the same lot number were obtained for evaluation.The retained samples showed no issues with safety shield breakage.Since the affected physical sample was not available for review, the retained samples showed no defect, and the picture could not provide an accurate evaluation for the defect, at this time a cause related to the manufacturing process could not be determined.If the affected sample becomes available for this incident or any potential future incidents, we would greatly appreciate the opportunity to conduct a thorough analysis.The material used to manufacture eclipse needles has been selected and tested to resist normal conditions of use.The assembly process has a system that inspects all needles for proper opening and activation of the safety shield, rejecting any defective products identified.Every lot is tested prior to release for final safety shield activation test (the force required to activate the eclipse hypodermic safety needle product) and this lot was released in compliance with specifications.Considering the preventive measures in place, we believe it is a low probability that the shield was damaged prior to use.We cannot discard the handling of the product as a possible impacting factor in this event.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE ECLIPSE S/T 30X1/2 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, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23451786
• Report Number: 2243072-2025-01340
• Device Sequence Number: 15693554
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(10)2411006
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 305892
• Device Lot Number: 2411006
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown