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 368836

Device Problem Material Separation (1562)

Patient Problem Discomfort (2330)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 that during use with 3 bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder the holder separated from the needle.Patient had discomfort as the sample had to be retaken.The following information was provided by the initial reporter: holder detaches from the needle during phlebotomy (when the needle is in the patients arm).The phlebotomist had to retake the samples and the patient felt uncomfortable.

Manufacturer Narrative

The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 04-oct-2023.H.6 investigation summary: bd received 1 used sample and 6 photos for investigation.The photos were reviewed and the indicated failure mode for cracked holder was observed.The sample could not be assessed due to it being contaminated with blood.Additionally, 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 vacutainer tubes with water, and the issue of cracked holder 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 cracked holder.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that during use with 3 bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder the holder separated from the needle.Patient had discomfort as the sample had to be retaken.The following information was provided by the initial reporter: holder detaches from the needle during phlebotomy (when the needle is in the patients arm).The phlebotomist had to retake the samples and the patient felt uncomfortable.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17801699
• MDR Text Key: 324151945
• Report Number: 9617032-2023-01228
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 368836
• Device Lot Number: 3142290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2023
• 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