MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367001
Medical Device Problem Codes	Crack (1135); Excessive Cooling (2932)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.E1.Initial reporter phone #: additional phone number: (b)(6) 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 vacutainer® blood alcohol determinations tube, an unspecified number of tubes were stored in a freezer at temperatures below -20°c and are breaking under freezing conditions.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported while using bd vacutainer® blood alcohol determinations tube, an unspecified number of tubes were stored in a freezer at temperatures below -20°c and are breaking under freezing conditions.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd received one photo for investigation.The photo was evaluated and does not show the customer¿s indicated failure mode.The labels were printed according to the current labeling requirement.Additionally, 100 retained samples were visually inspected, with no issues being identified.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.This complaint has not been confirmed for the indicated failure modes: cracked product/component and storage.No definitive root cause could be established for the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for the identification of emerging trends.

• Brand Name: BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: anand singh ; 1 becton drive; franklin lakes, NJ 07417 ; 2018475186
• MDR Report Key: 23328404
• Report Number: 1917413-2025-01435
• Device Sequence Number: 10611930
• Product Code: JKA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• 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: 11/30/2025
• Device Catalogue Number: 367001
• Device Lot Number: 3318966
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/11/2025; Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/03/2025; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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