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

Catalog Number	305760
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
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 eclipse needle stick injury occurred.The following information was provided by the initial reporter, translated from french to english: i would like to inform you that one of our nurses has reported a material safety event.It concerns a bd eclipse needle.In fact, when our nurse disassembled a syringe from her needle, with the safety device in place beforehand, she still pricked herself.This event had major and immediate consequences for the caregiver: an aes.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305760 and lot number 2304004.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, a thorough sample analysis could not be completed.At this time, an exact cause could not be determined for this incident.However, we would like to inform you that every single lot produced is tested prior to release with a final safety shield activation test.The reported lot was released in compliance with specifications.In addition, our assembly process has a system that inspects 100% of the product for proper opening and activation of needles safety shields, with any defective product rejected.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.H3 other text : see narrative below.
Event or Problem Description
No additional information.

• Brand Name: BD ECLIPSE
• Common Device Name: NEEDLE, 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: 18551288
• Report Number: 3002682307-2024-00008
• Device Sequence Number: 7596993
• Product Code: FMI
• UDI-Device Identifier: 50382903057608
• UDI-Public: (01)50382903057608
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 305760
• Device Lot Number: 2304004
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown