MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367525

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k2e (edta) 18.0mg plus blood collection tube the tube was used after the expiration date." the following information was provided by the initial reporter.The customer stated: "we have been working in medical genetics and using bd vacutainer and other products for the last 20 years.Currently, we are facing a huge problem as suppliers are providing us fake/expired bd vacutainer with re-labelling as well syringes due to which we lost a lot of our precious blood samples.".

Manufacturer Narrative

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 when using the bd vacutainer® k2e (edta) 18.0mg plus blood collection tube the tube was used after the expiration date." the following information was provided by the initial reporter.The customer stated: "we have been working in medical genetics and using bd vacutainer and other products for the last 20 years.Currently, we are facing a huge problem as suppliers are providing us fake/expired bd vacutainer with re-labelling as well syringes due to which we lost a lot of our precious blood samples.".

Manufacturer Narrative

H.6.Investigation summary: bd received a photograph from the customer in support of this complaint.The evaluation of the shelf pack label in the photograph was identical compared with the retained samples of the bd inventory.Bd was unable to duplicate or confirm the customer¿s indicated failure mode based on the visual check of retained samples.Bd was not able to identify a root cause for the indicated failure mode.A complaint history review was conducted and only the current complaint was found relating to the incident lot number 1245679 and the ¿as reported¿ defect code.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements.

• Brand Name: BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15741574
• MDR Text Key: 307634576
• Report Number: 9617032-2022-01102
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 367525
• Device Lot Number: 1245679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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