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

Catalog Number	365975
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	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 analyzing blood samples collected in bd microtainer® k2e tubes, the blood samples coagulated.This occurred ten (10) times.The blood samples were recollected.There was no report of adverse impact to patients or users.
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: 09-sep-2024.Investigation summary: material #: 365975.Lot/batch #: 4044896.Bd received 50 samples for investigation.The samples were evaluated by visual examination for presence of additive and 15 samples underwent titration testing for quantity of additive 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 for presence of additive and 15 retention samples underwent titration testing for quantity of additive 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 august 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 analyzing blood samples collected in bd microtainer® k2e tubes, the blood samples coagulated.This occurred ten (10) times.The blood samples were recollected.There was no report of adverse impact to patients or users.

• Brand Name: BD MICROTAINER® K2E TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20180396
• Report Number: 2618282-2024-00121
• Device Sequence Number: 15634049
• Product Code: JKA
• UDI-Device Identifier: 30382903659754
• UDI-Public: (01)30382903659754
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 07/31/2025
• Device Catalogue Number: 365975
• Device Lot Number: 4044896
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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