MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 65 UNITS; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367961
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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 when using bd vacutainer® pst¿ gel and lithium heparinn 65 units, there was poor sample quality with particulate matter in the plasma of an unspecified number of devices.Tubes that are re-centrifuged begin to show elevated test results.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported when using bd vacutainer® pst¿ gel and lithium heparinn 65 units, there was poor sample quality with particulate matter in the plasma of an unspecified number of devices.Tubes that are re-centrifuged begin to show elevated test results.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary: bd had not received any samples or photos for investigation.A total of 100 retained samples were inspected, with no issues being identified.No difficulties were encountered during blood collection as all tubes exhibited proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure mode, erroneous results-sodium, potassium, chloride, because the defect was not evident in the testing of the complaint lot samples.Replicates of both retention and control samples tested were acceptable in terms of both precision and accuracy.Complaints for sample quality are under statistical control for the month of may 2025.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.This complaint has not been confirmed for the indicated failure modes: erroneous results-sodium, potassium, chloride and sample quality-poor plasma.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.Bd quality will continue to monitor sample quality complaints.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 65 UNITS
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22349616
• Report Number: 1917413-2025-00847
• Device Sequence Number: 8519794
• Product Code: JKA
• UDI-Device Identifier: 30382903679615
• UDI-Public: (01)30382903679615(11)241113(17)251130(10)4318906
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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): 11/18/2025

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: 367961
• Device Lot Number: 4318906
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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