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

Catalog Number	305760
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd needle eclipse needle broke off.The following information was provided by the initial reporter, translated from dutch to english: during the period of administering the flu shot by the healthcare institutions, we received a complaint about one of your items.I had 2x that the protective cover flew off while i wanted to put it on.And a colleague had 1x that the needle broke off itself at the protective cover.Fortunately, no incidents have arisen from it.
Additional Manufacturer Narrative
Correction: product expert review: from my point of view the issue the costumer experienced is that one: the safety shield disengaged, it can be because the safety shield broke off or because the needle pivot (part where the safety shield is assembled in the hub) breaks.They do not believe that the failure needle broke occurred.Investigation: a device history record review was completed for provided material number 305760 and lot number 2403008.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 the same lot number were obtained from the manufacturing facility for evaluation.The samples were inspected and no defects were observed with the safety mechanisms.It was possible to activate the safety shield by following the instructions for use.Based on the investigation results, an exact cause could not be determined for the reported incident.Each lot produced is tested prior to final release for safety shield activation.The assembly process has an inspections system which inspects all product for proper opening/activation of the safety shield.Regarding the issue of needle broke off itself at the protective cover, we understand the defect refers to safety shield broke off at the needle pivot and not needle broken.Based on the preventive measures in place, we believe this was an isolated incident 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: 21163478
• Report Number: 3002682307-2025-00002
• Device Sequence Number: 18115798
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: (01)50382903057608(11)240306(17)290228(10)2403008
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 305760
• Device Lot Number: 2403008
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown