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

Catalog Number 368650

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

E.4: the initial reporter notified the fda on dd-mmm-yyyy.Medwatch report # (b)(4)h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd vacutainer® eclipse¿ blood collection needle with pre-attached holder, the safety shield detached from two needles.No patient impact reported.

Manufacturer Narrative

The following field have been updated with a correction: e.4: medwatch report #2400010000-2023-8029.The initial reporter notified the fda on: 01-dec-2023.After further evaluation of the complaint, it has been determined that, the previous medwatch report # provided on e.4: "the initial reporter notified the fda on dd-mmm-yyyy.Medwatch report # 2400010000-2023-8026 and 2400010000-2023-8025" was sent in error, the correct report # is 2400010000-2023-8029.The exact day was unknown, so 1st day of the month has been used.H.6.Investigation summary: material #: 368650, lot/batch #: 3223399.Bd had not received samples or photos for investigation.Therefore, 20 retention samples from bd inventory were evaluated by functional testing, each having their eclipse shield activated, and no issues were observed relating to defective locking mechanism as all samples met specifications.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 is unable to be confirmed for the indicated failure mode defective locking mechanism.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that while using bd vacutainer® eclipse¿ blood collection needle with pre-attached holder, the safety shield detached from two needles.No patient impact reported.

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
• Type of Device: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18613838
• MDR Text Key: 335088720
• Report Number: 1024879-2024-00071
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903686501
• UDI-Public: (01)50382903686501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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
• Device Operator: Other
• Device Catalogue Number: 368650
• Device Lot Number: 3223399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1