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

Catalog Number	305770
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd needle eclipse safety shield broke off.The following information was provided by the initial reporter: the protective caps that are folded over the cannula after use fell off and the cannulas had to be disposed of in the puncture-proof disposal boxes without any safety protection.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305770 and lot number 2502009.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, five (5) unused eclipse needles were received for evaluation by our quality team.Through examination of the samples, the safety shield mechanisms were found to be without any damage.No abnormalities were identified with the samples.The sample needles were assembled with a bd discardit 5ml syringe, and the safety shields were activated without any problem.Based on the sample evaluation, the reported issue could not be reproduced.With the investigation results, an exact cause could not be determined for the reported events.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.We would like to inform you that the material used to manufacture eclipse needles has been selected and tested to resist normal conditions of use.In addition, our assembly process has a system that inspects 100% of the needles for proper opening and activation of the safety shield, rejecting any defective product identified.In addition, every batch is tested prior to release for final safety shield activation testing (the force required to activate the eclipse hypodermic safety needle product).We can confirm that the reported lot was released in compliance with specifications.Based on the preventive measures in place, we believe the probability of this defect is very low within the manufacturing process.On the other hand, we cannot discard the possibility that the handling of the product could have had an impact on the issue reported.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: ECLIPSE SMARTSLIP
• 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: 22613776
• Report Number: 3002682307-2025-00094
• Device Sequence Number: 9603827
• Product Code: FMI
• UDI-Device Identifier: 00382903057702
• UDI-Public: (01)00382903057702(11)250213(17)300131(10)2502009
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Catalogue Number: 305770
• Device Lot Number: 2502009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown