MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367925
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® sodium fluoride/potassium oxalate 15mg/12mg, the customer had clotting issues on unspecified number of tubes.No patient impact reported.
Additional Manufacturer Narrative
E1: initial reporter phone and email: (b)(6).Investigation summary: bd had not received samples or photos for investigation.Therefore, 100 retention samples from bd inventory were evaluated by visual examination and no gel issues were observed relating to clotting as all samples met specifications.Complaints for sample quality are under statistical control for the month of september 2024.At this time, further testing is not indicated.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 of clotting.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.Bd quality will continue to monitor sample quality complaints.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 15MG/12MG
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20515263
• Report Number: 1917413-2024-00994
• Device Sequence Number: 8497601
• Product Code: JKA
• UDI-Device Identifier: 30382903679257
• UDI-Public: (01)30382903679257(11)240214(17)250731(10)4045251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: 07/31/2025
• Device Catalogue Number: 367925
• Device Lot Number: 4045251
• 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: 09/25/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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