MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	363706
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 21-oct-2024.Investigation summary.Material #: 363706.Lot/batch #: 4050319.Bd received 18 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for clotting with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to clotting as all samples met specifications.Complaints for sample quality are under statistical control for the month of oct 2024.At this time, further testing is not indicated.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 clotting.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.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported while using bd microtainer® map microtubes for automated process k2 edta 1.0 mg the blood samples clotted.This occurred with an unspecified number of tubes.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
B3.Date of event is unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd microtainer® map microtubes for automated process k2 edta 1.0 mg the blood samples clotted.This occurred with an unspecified number of tubes.There was no report of adverse impact to patients or users.

• Brand Name: BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20567149
• Report Number: 1917413-2024-01016
• Device Sequence Number: 15323665
• Product Code: JKA
• UDI-Device Identifier: 30382903637066
• UDI-Public: (01)30382903637066(11)240219(17)250831(10)4050319
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 363706
• Device Lot Number: 4050319
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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