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

Catalog Number	305760
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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 design of these needles is very poor quality.They require a great deal of force to get the needle to secure onto a syringe with a luer-lok.I have found the pink safety lock has broken off a few times prior to administration.I have had to replace these needles multiple times for my own safety, to prevent a needle stick injury.Level of harm: no effect - did not reach patient/person -- detected before use or does not touch patient during use.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305760 and lot number 2011006.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) physical sample was received for evaluation by our quality team.Through examination of the sample, it was observed that the snap clip was activated.Based on the sample results, no manufacturing related defects were identified, and an exact cause could not be determined for the reported issue.It is possible that the handling of the product had an implication in the reported event.Each lot manufactured is tested prior to release for final safety shield activation testing (the force required to activate the eclipse hypodermic safety needle product).Lot number 2011006 was released in compliance with specifications.The assembly process has a system that inspects all needles for proper opening and activation of the safety shield, rejecting any defective product identified.Based on the preventive measures in place, we believe the probability of this defect is very low with an unlikely chance of recurrence.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: 22777955
• Report Number: 3002682307-2025-00099
• Device Sequence Number: 9167037
• Product Code: FMI
• UDI-Device Identifier: 00382903057603
• UDI-Public: (01)00382903057603(11)201104(17)251031(10)2011006
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 2011006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown