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

Catalog Number	302437
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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 eclipse.The following information was provided by the initial reporter, translated from german to english: when activating the protective cap, it simply broke off.Without the use of force! when did the incident occur? during use.
Event or Problem Description
(b)(6) 2025: after consultation, i can confirm that there were no patient or user injuries.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 302437 and lot number 2411008.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, two (2) picture samples and the affected physical sample were returned for evaluation by our quality team.Through examination of the sample, the needle was observed without the safety shield assembled and a ¿loose¿ safety shield.Disassembly was observed with the product components; however, no broken piece was observed.Twenty (20) additional retained samples of the reported lot number were obtained from the manufacturing facility.The retained samples were inspected and no defects were observed in the safety mechanisms.All of the retained sample safety shields could be activated following the instructions for use.Based on the sample review, we understand that this incident resulted from the safety shield not being assembled onto the needle.We would like to inform you that our assembly process has an inspection system in place which inspects all product for proper opening and activation of the safety shield, rejecting any defects identified.We understand that this issue could have resulted from a temporary failure during manufacture.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.

• 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: 21421484
• Report Number: 3002682307-2025-00025
• Device Sequence Number: 20774337
• Product Code: FMI
• UDI-Device Identifier: 00382903024377
• UDI-Public: (01)00382903024377(11)241111(17)291031(10)2411008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: UNK
• 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): 03/10/2025

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: 302437
• Device Lot Number: 2411008
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown