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

Catalog Number	365974
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.5.Initial reporter phone #: (b)(6).H.6.Investigation summary: bd had not received samples, but 5 photos were provided for investigation.The photos were reviewed and the indicated failure mode for torn label was observed in one of the photos.Retention samples were not available for inspection.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, torn label.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 or Problem Description
It was reported prior to using the bd microtainer® tubes with k2e (k2edta) the label on the box was torn.There was no report of impact on the patient or user.

• Brand Name: BD MICROTAINER® TUBES WITH K2E (K2EDTA)
• Common Device Name: 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: 19212055
• Report Number: 2618282-2024-00034
• Device Sequence Number: 7016695
• Product Code: JKA
• UDI-Device Identifier: 30382903659747
• UDI-Public: (01)30382903659747
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K940905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 365974
• Device Lot Number: 3178234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown