MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367863

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tube the tube was used after the expiration date.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "we ended up having a lot that expired.The lot was not expired upon receipt and we had it on the shelf for too long and it had expired." customer states three samples were collected in the expired lot and need to know if the samples were impacted.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: bd had not received samples or photos for evaluation.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.Due to product being expired, no manufacturing investigation can be completed.As noted in bds instructions for use (ifu), do not use tubes after their expiration date.Tubes expire on the last day of the month and year indicated.This complaint is unable to be confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 10.8mg blood collection tube the tube was used after the expiration date.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "we ended up having a lot that expired.The lot was not expired upon receipt and we had it on the shelf for too long and it had expired." customer states three samples were collected in the expired lot and need to know if the samples were impacted.".

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 10.8MG BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13114510
• MDR Text Key: 285015349
• Report Number: 1917413-2021-01091
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678636
• UDI-Public: 50382903678636
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Model Number: 367863
• Device Catalogue Number: 367863
• Device Lot Number: 0072512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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