MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information is as follows: g.4.Pma / 510(k)#: k954592.Investigation summary: bd received a photo for investigation.The photo shows foreign matter in tube, but there is no air bubbles in gel.In addition, 100 retained samples were visually inspected, with one sample containing an air bubble.The defect rate is within specification limits, so no further action is required.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: foreign matter - non-biological and gel airbubbles.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 heparin 56 units, foreign matter was found in 154 tubes and there was 476 tubes with air bubbles.No adverse impact was reported regarding the patient or user.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN 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: 24866838
• Report Number: 1917413-2026-00282
• Device Sequence Number: 18483646
• 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
• Report Date (Section B): 03/19/2026

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: 03/17/2026
• Initial Report FDA Received Date: 04/13/2026
• 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