MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® Z (NO ADDITIVE TUBES); TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	365963
Medical Device Problem Codes	Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 4060065.D4.Medical device expiration date: 31-aug-2025.H4.Device manufacture date: 29-feb-2024.D4.Unique identifier (udi) #: (b)(4).D4.Medical device lot #: 4015971.D4.Medical device expiration date: 30-jun-2025.H4.Device manufacture date: 15-jan-2024.D4.Unique identifier (udi) #: (b)(4).E1.Initial reporter addr 1: (b)(4).E1.Initial reporter facility name: (b)(4).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® z (no additive tubes) 10 samples had poor serum(not separated properly), fibrin, and caps opened in the centrifuge.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but 6 photos were provided for investigation.The photos were reviewed and the indicated failure mode for decapping was observed in one photo.Fibrin and poor serum could not be observed from the photos: the first photo shows a bd microtainer serum separator (red cap) tube inside a round tube holder.The second photo shows a microcollect (non-bd product) tube with a red cap inside the same tube holder.The third photo shows one bd microtainer and one microcollect (non-bd product) tube with red cap inside the centrifuge adapter in which the microtainer cap is loose while its corresponding tube is inside adapter hole, no blood leakage was observed.The fourth photo shows the inside of the centrifuge with different brand tubes (bd and non-bd product) inside the adapters.The fifth photo shows the centrifuge that is being used (model rotina 380).The sixth photo shows multiple brands of blood collection tubes standing inside a white tray.Additionally, retention samples from bd inventory were visually inspected and found to be in conformance and met release 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 has been confirmed for decapping.This complaint is unable to be confirmed for fibrin and poor serum.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® z (no additive tubes) 10 samples had poor serum (not separated properly), fibrin, and caps opened in the centrifuge.There was no health impact or consequences reported.

• Brand Name: BD MICROTAINER® Z (NO ADDITIVE TUBES)
• 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: 20250269
• Report Number: 2618282-2024-00130
• Device Sequence Number: 17991432
• Product Code: JKA
• Combination Product (Y/N): N
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2026

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: 02/28/2025
• Device Catalogue Number: 365963
• Device Lot Number: 3269911
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 09/26/2024; Not provided
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 09/27/2024; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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