MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH K2E (K2EDTA); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 365974

Device Problem Material Deformation (2976)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter facility name: (b)(6) hospital.H.6.Investigation summary: retention samples were evaluated with acceptable results.Fifty (50) retention samples were evaluated for damaged reservoirs/caps and cap assembly with acceptable results.No reservoirs or caps were observed to be broken, cracked or damaged.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, molding defect (cap defect).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.

Event Description

It was reported when using the bd microtainer® tubes with k2e (k2edta) the cap had a molding defect, and the caps were difficult to remove.There was no report of impact on the patient or user.

• Brand Name: BD MICROTAINER® TUBES WITH K2E (K2EDTA)
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19115286
• MDR Text Key: 340268577
• Report Number: 2618282-2024-00023
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903659747
• UDI-Public: (01)30382903659747
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K940905
• 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
• Report Date: 03/27/2024

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: 365974
• Device Lot Number: 3284460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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