MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365965
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
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® tubes with lh (lithium heparin) 10 tubes are clotting and are missing additive.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 and no issues relating to missing additive were observed.Additionally, 15 retention samples were functionally evaluated 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 and missing additive.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® tubes with lh (lithium heparin) 10 tubes are clotting and are missing additive.There was no health impact or consequences reported.
Event or Problem Description
It was reported while using bd microtainer® tubes with lh (lithium heparin) 10 tubes are clotting and are missing additive.There was no health impact or consequences reported.
Additional Manufacturer Narrative
This supplemental mdr is submitted to document that bd will no longer consider the specific malfunction identified below to be a reportable mdr malfunction for the specified product family.Consistent with fda's "medical device reporting for manufacturers" guidance (november 8, 2016, section 2.15), bd determined that this issue has not caused or contributed to a death or serious injury in the previous two years and that the likelihood of a death or serious injury occurring as a result is remote.Bd previously notified fda of this determination on january 8, 2026.Product family: bd microtainer® lithium heparin tubes specific malfunction: missing additive this mdr is being submitted as a representative notification for the product family and specific malfunction identified above and applies to all applicable catalog numbers within that product family associated with this issue.This determination applies only to the issue identified above when it occurs independently and does not otherwise meet mdr reporting requirements.Bd will continue to submit mdrs for reportable deaths, serious injuries, and reportable malfunctions, including events involving multiple event types where mdr reporting criteria are met.Future occurrences of this issue will no longer be submitted as standalone malfunction mdrs.Bd will continue to monitor complaint and adverse event data related to this issue and will reassess mdr reportability should new information indicate that reporting criteria may be met.

• Brand Name: BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN)
• 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: 19639403
• Report Number: 2618282-2024-00069
• Device Sequence Number: 12913996
• Product Code: JKA
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 09/05/2026

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: 365965
• Device Lot Number: 407348N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/30/2024; Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/06/2024; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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