MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	368651
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while removing the iv shield from a bd vacutainer® eclipse¿ blood collection needle with pre-attached holder the entire hub-collar separated from the device.The device was discarded.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while removing the iv shield from a bd vacutainer® eclipse¿ blood collection needle with pre-attached holder the entire hub-collar separated from the device.The device was discarded.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
Investigation summary - bd received one photo for investigation, which shows a device with the collar separated from the hub.Additionally, 20 retained samples were inspected for hub/collar separation and defective locking mechanisms.These samples passed testing, as there were no signs of damage or separation during the activation of the safety shield.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has been confirmed for the indicated failure mode: hub/collar separation.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20748027
• Report Number: 1024879-2024-01109
• Device Sequence Number: 20907276
• Product Code: FMI
• UDI-Device Identifier: 50382903686518
• UDI-Public: (01)50382903686518(11)240508(17)270430(10)4129902
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K982541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 368651
• Device Lot Number: 4129902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown