MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD NEEDLE 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	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse safety shield broke off.The following information was provided by the initial reporter: i have now had the lancing protection of your needles break off several times after use.Is there anything known about poor quality? there have been no needlestick injuries so far, but this has never happened with you before.Shield broken, previously 1-2 such incidents.You don't report it the first time.Probably a manufacturing defect.We have been using the needles for years and have never had any problems.
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
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305760 and lot number 2403006.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, two (2) needle samples were received for evaluation by our quality team.The needles were both opened and used and both needles presented broken safety shields.After examination, it can be confirmed that the safety shields broke from the ¿pivot¿ area (plastic part which is directly assembled to the hub component).(b)(4) retained samples of the same lot number were obtained from the manufacturing facility for an additional review.The retained sample safety shields could be activated properly without any issue.Considering the provided information, we understand that the reported defect took place during use, when the safety shield was activated.We would like to inform you that the material used to manufacture the eclipse needle has been selected and tested to resist normal conditions of use.In addition, our assembly process has a system that inspects all product for proper opening and activation of the safety shield, rejecting any defective product identified.We would like to inform you that every single lot is tested prior to release for final safety shield activation test (the force required to activate the eclipse hypodermic safety needle product).We can confirm that the reported lot was released within specifications.Based on this fact, we cannot discard that the handling of the product may have had an impact in 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.

• Brand Name: BD NEEDLE 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: 22084929
• Report Number: 3002682307-2025-00069
• Device Sequence Number: 6947363
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: (01)50382903057608
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 2403006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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