MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367856

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 11/19/2023

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes had three molding defect that inhibits the tubes inability to perform.There was no report of impact to patient or user.

Manufacturer Narrative

H.3.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® k2 edta (k2e) 5.4mg blood collection tubes had 2 molding defect that inhibits the tubes inability to perform.There was no report of impact to patient or user.

Manufacturer Narrative

The following fields have been updated with a correction: b5: describe event or problem: it was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes had 2 molding defect that inhibits the tubes inability to perform.There was no report of impact to patient or user.H.6.Investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for damaged tube was observed.The inside of the used tube had an indentation where plastic was peeled away from the sidewall.No photos of unused tubes have been returned exhibiting this damage.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of damaged tube 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.This complaint has been confirmed for the indicated failure mode of damaged tube based on photos.Bd was not able to identify an exact root cause for the indicated failure mode.Bd can confirm that nothing is introduced inside the tube during manufacturing that could cause this damage.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) 5.4MG 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18329422
• MDR Text Key: 330556630
• Report Number: 1917413-2023-01250
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678568
• UDI-Public: (01)50382903678568
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367856
• Device Lot Number: 3222718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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