MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368499

Device Problem Filling Problem (1233)

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

Event Date 10/29/2023

Event Type  malfunction  

Manufacturer Narrative

E.1 initial reporter addr 1: (b)(6).H.6 investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for underfill was observed.Additionally, twenty (20) retention samples from bd inventory were evaluated by functional testing and the issue of underfill 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.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 that while using the bd vacutainer® k2e 5.4mg plus blood collection tubes that it was noticed tubes were not filling properly, resulting in underfilled tubes.The following information was provided by the initial reporter: the customer complained that in the past two months, he found that about 6-7% of the 3ml purple head tubes (with an average daily dosage of 400 pcs) had insufficient negative pressure, which manifested itself as a flow rate of blood approximating to the speed of a drop, and even about 1% could not collect any blood samples at all, and it was suspected that there was no negative pressure.This situation occurred centrally in goods number 368499 lot number 3129795.

• Brand Name: BD VACUTAINER® K2E 5.4MG 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: 18208770
• MDR Text Key: 328997713
• Report Number: 9617032-2023-01688
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903684992
• UDI-Public: (01)30382903684992
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 11/01/2023

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: 368499
• Device Lot Number: 3129795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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