MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367861

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the user identified using the tubes after the expiration date.The following information was provided by the initial reporter.The customer stated: had been using epired tubes on their patients in order to collect blood specimens.Tubes expired on 2020 - 2021.The results from these tubes are not accurate and represents a problem for the patients.And process all their own specimens only for (b)(6) patients.The dx codes are: d64.9 e11.9 e78.5 e03.9 e55.9 110.

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

H.6.Investigation: bd had not received samples or photos for evaluation.Product is expired 2021-02-28.Bd can only assure the safety and efficacy of its products across their shelf-life.The products should only be used within their printed labeled expiry dates.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 expired tubes.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the user identified using the tubes after the expiration date.The following information was provided by the initial reporter.The customer stated: had been using epired tubes on their patients in order to collect blood specimens.Tubes expired on 2020 - 2021.The results from these tubes are not accurate and represents a problem for the patients.And process all their own specimens only for (b)(6) patients.The dx codes are: d64.9 e11.9 e78.5 e03.9 e55.9 110.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
• 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 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: 13934903
• MDR Text Key: 289020954
• Report Number: 1917413-2022-00157
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678617
• UDI-Public: 00382903678617
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 367861
• Device Lot Number: 9280916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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