MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367960
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers g4: pma / 510(k)#: k954592.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 prior to using bd vacutainer® pst¿ gel and lithium heparinn 56 units, foreign matter was found in 207 tubes and air bubbles were seen in 850 tubes.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
Investigation summary bd received one photo for investigation regarding the reported defect of air bubbles in the gel of the tube and foreign matter (fm).Evaluation of the photo confirmed the presence of fm in the tube; however, the photo does not show the customer¿s indicated failure mode of gel airbubbles.A total of 100 retained samples were visually inspected, and 1 retained sample contained an air bubble.Air bubbles are ambient air that can become trapped inside the gel of bd vacutainer® gel tubes during the manufacturing process.Air bubbles can be observed visually by the human eye in the gel before the tube is used for blood collection or prior to centrifugation.Ambient air can become trapped inside the gel of bd vacutainer® gel tubes during the processes of mixing, pumping and dispensing.Special precautions are taken during these processes to eliminate air within the gel.However, it is possible that a small amount of air remains trapped in the gel.In addition, the occurrence of air bubbles may also be influenced by environmental and shipping conditions.Bd product that is within specification may contain a low occurrence of air bubbles.Bd maintains strict manufacturing procedures to monitor size and quantity of air bubbles in gel tubes, including routine visual inspections, to ensure product meets specification.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 been confirmed for the indicated failure modes: gel airbubbles and molding defect.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.
Event or Problem Description
It was reported prior to using bd vacutainer® pst¿ gel and lithium heparinn 56 units, foreign matter was found in 207 tubes and air bubbles were seen in 850 tubes.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 56 UNITS
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON & CO (FRANKLIN LAKES); 1 becton drive; franklin lakes NJ 07417
• 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: 24703313
• Report Number: 1917413-2026-00197
• Device Sequence Number: 15996446
• Product Code: JKA
• UDI-Device Identifier: 30382903679608
• UDI-Public: (01)30382903679608(17)260831(10)5225554
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 08/31/2026
• Device Catalogue Number: 367960
• Device Lot Number: 5225554
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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