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 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

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 has been reported that the bd vacutainer® eclipse¿ blood collection needle has been found experiencing poor sleeve function.No patient impact was reported.The following has been provided by the initial reporter: there was a sleeve rupture (the rubber that covers the distal needle), causing the blood to leak inside the holder.The physical sample is not available for analysis.As immediate action, the sample acquisition was completed this same way.Since the issue happened at the end of procedure there was no necessity of another puncture.

Event Description

It has been reported that the bd vacutainer® eclipse¿ blood collection needle has been found experiencing poor sleeve function.No patient impact was reported.The following has been provided by the initial reporter: there was a sleeve rupture (the rubber that covers the distal needle), causing the blood to leak inside the holder.The physical sample is not available for analysis.As immediate action, the sample acquisition was completed this same way.Since the issue happened at the end of procedure there was no necessity of another puncture.

Manufacturer Narrative

H.6.Investigation summary: material #: 368607.Lot/batch #: 3012295.Bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for sleeve leakage was observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 10 vacutainer tubes, and the issue of sleeve leakage was not observed.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 sleeve leakage.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 18219125
• MDR Text Key: 329147077
• Report Number: 1024879-2023-00850
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903686075
• UDI-Public: (01)50382903686075
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,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: 368607
• Device Lot Number: 3012295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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