MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD MICROTAINER® MAP K2E (1.0 MG) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	363706
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd microtainer® map k2e (1.0 mg) blood collection tubes, an unspecified number of tubes exhibited condensation resulting in sample clotting.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.H3: device eval by manufacturer? yes.D9: returned to manufacturer on: 05-may-2025.Investigation summary: bd received one sample for investigation, which was visually inspected with no issues identified.It was then sent for a functional test, and the results were within specification limits.Additionally, 50 retained samples were visually inspected and no issues were identified.Complaints for sample quality are under statistical control for the month of march 2025.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has not been confirmed for the indicated failure modes: additive abnormality and clotting.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported while using bd microtainer® map k2e (1.0 mg) blood collection tubes, an unspecified number of tubes exhibited condensation resulting in sample clotting.No adverse impact was reported regarding the patient or user.

• Brand Name: BD MICROTAINER® MAP K2E (1.0 MG) BLOOD COLLECTION TUBES
• Common Device Name: 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21773630
• Report Number: 1917413-2025-00394
• Device Sequence Number: 18192820
• Product Code: JKA
• UDI-Device Identifier: 30382903637066
• UDI-Public: (01)30382903637066(11)250108(17)260630(10)5008100
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093972
• 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,Followup
• Report Date (Section B): 04/30/2025

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: 06/30/2026
• Device Catalogue Number: 363706
• Device Lot Number: 5008100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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