MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367921
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.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 while using bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg, an unspecified number of tubes were stored at incorrect temperature prior to use.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples for investigation.The device history records could not be reviewed as the lot number is unknown.This complaint has not been confirmed for the indicated failure mode: storage.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.
Event or Problem Description
It was reported while using bd vacutainer® sodium fluoride/potassium oxalate 5mg/4mg, an unspecified number of tubes were stored at incorrect temperature prior to use.There was no health impact or consequences reported.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22977607
• Report Number: 1917413-2025-01216
• Device Sequence Number: 21219818
• Product Code: JKA
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K231237
• 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,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 Catalogue Number: 367921
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 10/17/2025; Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/13/2025; 09/15/2026
• 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