MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K3E 3.6MG PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367858

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

E.1.(b)(6).H.6.Investigation summary: bd received 2 photos from the customer in support of this complaint, showing partially open shrink film around the shelf pack and missing shelf pack label.2 retained shelf packs were visually inspected, and no open seal or missing label was found.Bd was able to duplicate or confirm the customer¿s indicated failure modes with the photos provided.Bd was not able to identify the exact root cause for the indicated failure mode - missing label.There were no related quality notifications.All process and final inspections comply with specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® k3e 3.6mg plus blood collection tube the photo showed that there was no label on the shelf pack.There was no report of impact to the patient or user.

• Brand Name: BD VACUTAINER® K3E 3.6MG 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: 19213077
• MDR Text Key: 341614358
• Report Number: 9617032-2024-00667
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678587
• UDI-Public: (01)00382903678587
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367858
• Device Lot Number: 3282094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• 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