MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD NEEDLE ECLIPSE; NEEDLES, HYPODERMIC

Catalog Number	305760
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse poor connection needle to syringe.The following information was provided by the initial reporter: bd eclipse needle no longer securely leur locks in with the bd 3ml syringe (often used together by nurses to deliver subcutaneous injection/medications).The concern is that the connection point will disconnect at the point of injection causing potential blood and body fluid exposure/injury or loss/incorrect dosing of medication.At the time of the initial contact difficulty attaching the syringe to the needle could also cause injury and loss.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305760 and lot number 2011009.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) luer lock syringe and one (1) eclipse needle were returned for evaluation by our quality team.The eclipse needle had the snap clip (white plastic ¿ring¿) without activation.The needle was assembled onto the provided syringe and no issues were identified.Both devices could be connected and no leakage was observed.Please note that when assembling the eclipse needle with a luer lock syringe, a slightly rotational movement should be performed.We would like to inform you that smartslip technology ¿ has been introduced to help ensure a secure connection is made with luer slip syringes.Based on the investigation results, no manufacturing related issue or cause could be determined.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: BD NEEDLE ECLIPSE
• Common Device Name: NEEDLES, HYPODERMIC
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• 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: 22119265
• Report Number: 3002682307-2025-00070
• Device Sequence Number: 15191195
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: (01)50382903057608(11)201110(17)251031(10)2011009
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• 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 Expiration Date: 10/31/2025
• Device Catalogue Number: 305760
• Device Lot Number: 2011009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown