MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN); TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	365965
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd microtainer® tubes with lh (lithium heparin) 15 samples were clotted.The customer indicated tubes were underfilled and overfilled.The customer indicated the clotted samples were due to improper collection.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, 50 retention samples from bd inventory were visually inspected for additive with acceptable results.Additionally, 15 retain samples were functionally tested for additive quantity and all tubes tested within specification requirements.Complaints for sample quality are under statistical control for the month of (b)(6) 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 based on the investigation completed.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® TUBES WITH LH (LITHIUM HEPARIN)
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: 20197058
• Report Number: 2618282-2024-00124
• Device Sequence Number: 15364553
• Product Code: JKA
• UDI-Device Identifier: 30382903659655
• UDI-Public: (01)30382903659655
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: 365965
• Device Lot Number: 320234N
• 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: 08/13/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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