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	10/22/2021
Type of Reportable Event	Malfunction
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 and interfered with instruments.This occurred with an unspecified number of tubes.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.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 and interfered with instruments.This occurred with an unspecified number of tubes.There was no report of adverse impact to patients or users.
Additional Manufacturer Narrative
The following fields have been updated with additional information: e.1: initial reporter first name: (b)(6).E.1: initial reporter last name: (b)(6).E.1: initial reporter email: (b)(6).E.1: initial reporter phone #: (b)(6).Investigation summary: material #: 363706 lot/batch #: unknown bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.Complaints for sample quality are under statistical control for the month of october 2024.At this time, further testing is not indicated.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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.

• 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: 20713624
• Report Number: 1917413-2024-01075
• Device Sequence Number: 18617913
• Product Code: JKA
• UDI-Device Identifier: 30382903637066
• UDI-Public: (01)30382903637066
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 Catalogue Number: 363706
• Device Lot Number: UNKNOWN
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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