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); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd microtainer® map k2e (1.0 mg) blood collection tubes, there is condensation in an unspecified number of tubes resulting in sample clotting.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1917413-2025-00564 was sent in error as it was a duplicate of pr#(b)(4), mfr report # 1917413-2025-00349.
Event or Problem Description
It was reported while using bd microtainer® map k2e (1.0 mg) blood collection tubes, there is condensation in an unspecified number of tubes 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: 21946431
• Report Number: 1917413-2025-00564
• Device Sequence Number: 9056056
• Product Code: JKA
• UDI-Device Identifier: 30382903637066
• UDI-Public: (01)30382903637066(11)240219(17)250831(10)4050322
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 08/31/2025
• Device Catalogue Number: 363706
• Device Lot Number: 4050322
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• 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