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

Catalog Number	305892
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305892 and batch number 2411006.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples of reported lot number were obtained from the manufacturing facility.The needles were assembled with a bd discardit syringe; however, no signs of defective hub connection were identified.Based on the investigation results, we were unable to reproduce the reported issue and an exact cause could not be determined.Engagement force is measured during manufacture as part of the in-process inspections and final testing prior to release.Smartslip technology has been introduced to ensure that a secure connection is made with luer slip syringes.We recommend following the instructions for use, which are unique in directing the user to push firmly when attaching the needle to the syringe and to be sure that the clip is activated.Also, needles are manufactured and released according to applicable procedures and complies with international standard iso.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
It was reported that bd needle eclipse difficult/poor connection with leakage.The following information was provided by the initial reporter: difficult to attach to when did the incident occur - during use customer explains: "the needles we ordered from you, called bd eclipse needle 23 g (0.6 mm x 25 mm), are difficult to attach to, for example, gardasil9.These needles have likely caused vaccine leakage during the luer lock connection".Follow-up response received on 10-jun-2025: was the device being used in/on patient when the issue occurred? yes was patient or user harmed? if yes, please explain - no was the hcp present when the issue occurred? yes if leakage occurred, please confirm the fluid that leaked.The needle does not fit the syringe, leakage occurred as it does not seal properly was additional medical intervention/medication required? if yes, please explain no.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.D.The lot number 2411006 provided cannot be verified in association with the reported material number.

• 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: 22323037
• Report Number: 3002682307-2025-00084
• Device Sequence Number: 8794091
• Product Code: FMI
• UDI-Device Identifier: 00382903058921
• UDI-Public: (01)00382903058921(10)2411006
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown