MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	368650
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k982541.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that after using the bd vacutainer® eclipse¿ blood collection needle pre-attached holder, the safety mechanism was observed to be broken on an unspecified number of units.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Bd received one photo for investigation.The customer-provided photo shows a device with a broken safety shield that does not fully cover the iv cannula; however, the photo quality is not clear enough to evaluate needle point integrity.Therefore, 30 retained samples were visually inspected for cannula defects, including bent cannula and needle point integrity, and all samples passed testing with no evidence of damage or poor needle point integrity.Furthermore, 10 retained samples underwent a functional test for iv lube coverage, and all samples passed testing with sufficient lube coverage on the iv cannula.Additionally, 20 retain samples were subjected to a visual functional test for defective locking mechanism.The samples passed testing as all the samples were activated properly with no signs of damaged/broken safety shields.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode: damaged.This complaint has not been confirmed for the indicated failure mode: needle point integrity.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for the identification of emerging trends.
Event or Problem Description
It was reported that after using the bd vacutainer® eclipse¿ blood collection needle pre-attached holder, the safety mechanism was observed to be broken on an unspecified number of units.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23950672
• Report Number: 1024879-2025-02320
• Device Sequence Number: 10683401
• Product Code: JKA
• UDI-Device Identifier: 50382903686501
• UDI-Public: (01)50382903686501(11)250501(17)280430(10)5121520
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K243207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 368650
• Device Lot Number: 5121520
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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