MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367841

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 08/03/2022

Event Type  malfunction  

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 that bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes have blood pooling.The following information was provided by the initial reporter: "customer is reporting blood pooling on the cap of product 367841.".

Event Description

It was reported that bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes have blood pooling.The following information was provided by the initial reporter: "customer is reporting blood pooling on the cap of product 367841.".

Manufacturer Narrative

The following fields have been updated with additional information: d.9.Device available for eval? yes.D.9 returned to manufacturer on: 23-aug-2022.H.6.Investigation summary: bd received 1 sample and 1 photo for investigation.The photo was reviewed and the indicated failure mode for blood pooling was observed.Additionally, the customer sample along with 10 retention samples from bd inventory, were evaluated by functional testing and the issue of blood pooling 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.Bd was able to confirm the customer¿s indicated failure mode from the photos provided; however, the customer¿s failure mode could not be duplicated in the sample and retention testing.Bd was not able to identify a root cause for the indicated failure mode.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.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG 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 & 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: 15260184
• MDR Text Key: 305383866
• Report Number: 1917413-2022-00520
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678414
• UDI-Public: 50382903678414
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 367841
• Device Catalogue Number: 367841
• Device Lot Number: 1350317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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