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 Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).E1.Initial reporter phone #: (b)(6).D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.Investigation summary: 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 february 2025.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.
Event or Problem Description
It was reported during use of bd microtainer® z (no additive tubes), 4 tubes contained fibrin clots.There was no health impact or consequences reported.
Event or Problem Description
It was reported during use of bd microtainer® z (no additive tubes), 4 tubes contained fibrin clots.There was no health impact or consequences reported.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2618282-2025-00019 included an incorrect date due of 03-mar-2025.The original mdr had a date received by manufacture of 03-feb-2025 with an incorrect date due of 03-mar-2025.The date due was 05-mar-2025.

• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21521683
• Report Number: 2618282-2025-00019
• Device Sequence Number: 9584599
• 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): 09/04/2026

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 Catalogue Number: 365963
• Device Lot Number: UNKNOWN
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 03/05/2025; Not provided
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/14/2025; 09/14/2026
• 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