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

Catalog Number 368607

Device Problem Leak/Splash (1354)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® eclipse¿ blood collection needle that a single incident of blood leakage occurred while switching tubes during collection.No health impact or consequence reported.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 2023-december -4th.H.6 investigation summary: bd received 5 samples for investigation.The samples were evaluated by functional testing, each used to draw 10 vacutainer tubes, and the indicated failure mode for sleeve leakage with the incident lot was not observed as all product specifications were met.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 sleeve leakage.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 identification of emerging trends.".

Event Description

It was reported when using the bd vacutainer® eclipse¿ blood collection needle that a single incident of blood leakage occurred while switching tubes during collection.No health impact or consequence reported.

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
• 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: 18170859
• MDR Text Key: 328639183
• Report Number: 1024879-2023-00837
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903686087
• UDI-Public: (01)00382903686087
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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: 368607
• Device Lot Number: 3186630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• 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