MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 363048

Device Problem Filling Problem (1233)

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

Event Date 12/22/2023

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 that during use with the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tube, there was an issue with the fill volume.The customer did not specify if the tubes underfilled or overfilled.Attempts were made to obtain additional information, but none was provided.There was no report of patient impact.

Event Description

It was reported that during use with the bd vacutainer® 9nc 0.109m buffered trisodium citrate plus blood collection tube, there was an issue with the fill volume.The customer did not specify if the tubes underfilled or overfilled.Attempts were made to obtain additional information, but none was provided.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, twenty (20) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill or overfill as all samples met specifications.20 retained samples were draw-tested with deionized water.From this testing, it was determined that all 20 tubes drew within specification.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 underfill or overfill.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.

• Brand Name: BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES
• 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: 18540221
• MDR Text Key: 333209041
• Report Number: 9617032-2024-00048
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630481
• UDI-Public: (01)50382903630481
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K013971
• 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: 363048
• Device Lot Number: 3282107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2023
• 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