MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Catalog Number	366603
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient 2 of 9: it was reported while using bd minidraw¿ h&h capillary blood collection tube, 1 patient sample had platelet aggregates.A recollect was performed if patient agreed.There was no other health impact or consequences reported.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd received your customer complaint related to platelet clumping.It is important to note that usage of this product for platelet count is considered an off-label use.The intended use is limited to sample collection used in the measurement of hemoglobin (hgb) & hematocrit (hct), when analyzed on sysmex xn - series systems.Limitation notes are included in the ifu and printed on the tube unit label.Bd had not received samples or photos for investigation.Therefore, forty-five (45) retention samples were visually evaluated for dry additive appearance, and eight (8) samples were functionally evaluated via titration for edta content with all samples tested within specification requirements.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 platelet clumping.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.
Event or Problem Description
Patient 2 of 9: it was reported while using bd minidraw¿ h&h capillary blood collection tube, 1 patient sample had platelet aggregates.A recollect was performed if patient agreed.There was no other health impact or consequences reported.

• Brand Name: BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE
• Common Device Name: TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 24254247
• Report Number: 2618282-2026-00016
• Device Sequence Number: 8233825
• Product Code: GIM
• UDI-Device Identifier: 30382903666035
• UDI-Public: (01)30382903666035(17)260131(10)4215431
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230493
• 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
• Report Date (Section B): 03/17/2026

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: 01/31/2026
• Device Catalogue Number: 366603
• Device Lot Number: 4215431
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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