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

Catalog Number	305895
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 hub is damaged.The following information was provided by the initial reporter translated from portuguese to english: moving part inside the luer-lock connection customer does not specify the incident 18 dec 2024 the apparent problem, and in the analysis of the root cause, was considered as a conditioning condition of the accident, we consider it to be the absence of unequivocal information about the way dm was used.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305895 and lot number 2310007.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.To aid in the investigation of this issue, one (1) eclipse needle was returned for evaluation by our quality team.The needle had the snap clip already activated, and no related issue was observed.The needle was assembled with a bd emerald 5ml syringe.No signs of defective hub connection or leakage were detected.Based on the investigation results, an exact cause related to the manufacturing process could not be determined.Smartslip technology ¿ has been introduced to help ensure a secure connection has been made with luer slip syringes.It has been designed to reduce the risk of needle disengagement from luer slip syringes, which are the most common syringe design (in europe).We recommend closely following the instructions for use, which are unique in recommending that the user ¿push firmly when attaching the needle to the syringe¿ and to be sure that the ¿clip¿ is activated.The clip acts as an indicator that a suitable force has been applied to engage the needle hub.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 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: 21076133
• Report Number: 3002682307-2024-00264
• Device Sequence Number: 17836109
• Product Code: FMI
• UDI-Device Identifier: 00382903058952
• UDI-Public: (01)00382903058952(11)230927(17)280930(10)2310007
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: Other
• Device Catalogue Number: 305895
• Device Lot Number: 2310007
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/05/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown