MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368835

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/15/2024

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 was reported that when using the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder, there were three occurrences where the tube holder separated from the hub of the needle.No patient impact or injury reported.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.D10: device available for evaluation: yes d10: returned to manufacturer on: 22-mar-2024.H.6.Investigation summary: material #: 368835 lot/batch #: 3242438 bd received 54 samples and 2 photos for investigation.The photos were reviewed, and they show the product packaging.Additionally, 10 of the customer samples were evaluated by functional draw testing and the indicated failure modes for hub-holder separation and leakage with the incident lot were 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.While bd was unable to confirm this complaint for the indicated failure mode hub-holder separation, bd has initiated further root cause investigation relating to the issue of hub-holder separation through corrective and preventive actions.Bd was not able to identify a root cause for the leakage failure mode.

Event Description

It was reported that when using the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder, there were three occurrences where the tube holder separated from the hub of the needle.No patient impact or injury reported.

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18856653
• MDR Text Key: 337538484
• Report Number: 9617032-2024-00303
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903688358
• UDI-Public: (01)30382903688358
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 368835
• Device Lot Number: 3242438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2023
• 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