MAUDE Adverse Event Report: BD CARIBE LTD. BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE; CAPILLARY BLOOD COLLECTION TUBE IVD

Catalog Number	366604
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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 when using the bd minidraw¿ sst¿ capillary blood collection tube there was sample hemolysis in one device.The sample was recollected.There were no other health consequences or impacts reported.

• Brand Name: BD MINIDRAW¿ SST¿ CAPILLARY BLOOD COLLECTION TUBE
• Common Device Name: CAPILLARY BLOOD COLLECTION TUBE IVD
• 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: 21969408
• Report Number: 2618282-2025-00032
• Device Sequence Number: 12870863
• Product Code: JKA
• UDI-Device Identifier: 50382903666046
• UDI-Public: (01)50382903666046(11)240809(17)260131(10)4222834
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230391
• 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): 04/24/2025

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: 01/31/2026
• Device Catalogue Number: 366604
• Device Lot Number: 4222834
• 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: 04/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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