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 Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd minidraw h&h capillary blood collection tube, platelet clumping was seen with one patient sample.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported while using bd minidraw h&h capillary blood collection tube, platelet clumping was seen with one patient sample.No adverse impact was reported regarding the patient or user.
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 instruction for use (ifu) and printed on the tube unit label.Bd had not received samples or photos for investigation.Therefore, 45 retention samples from both lot numbers were visually inspected with no issues identified.Additionally, 16 retain samples from lot 5153525 were functionally tested for edta additive mass via titration and all samples were within specification limits.Furthermore, 37 retain samples from lot 5153525 were visually evaluated for print quality with no issues identified.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 modes sample quality.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.

• 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: 25032112
• Report Number: 2618282-2026-00089
• Device Sequence Number: 10186140
• Product Code: GIM
• UDI-Device Identifier: 30382903666035
• UDI-Public: (01)30382903666035(17)261130(10)5153525
• 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): 05/28/2026

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: 366603
• Device Lot Number: 5153525
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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