MAUDE Adverse Event Report: BECTON DICKINSON & CO (FRANKLIN LAKES) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367962
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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 while using bd vacutainer® pst¿ gel and lithium heparin (lh) 83 units blood collection tubes, there was missing gel that caused two (2) tubes to have poor separation.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported while using bd vacutainer® pst¿ gel and lithium heparin (lh) 83 units blood collection tubes, there two (2) tubes with poor separation.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The mdr submitted with mfr report #: 1917413-2026-00252 was submitted with the incorrect event and is considered a non reportable malfunction.This mdr is considered cancelled.

• Brand Name: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) 83 UNITS BLOOD COLLECTION TUBES
• 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: 24818524
• Report Number: 1917413-2026-00252
• Device Sequence Number: 18565333
• Product Code: JKA
• UDI-Device Identifier: 30382903679622
• UDI-Public: (01)30382903679622(17)260930(10)5269485
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/20/2026

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: 09/30/2026
• Device Catalogue Number: 367962
• Device Lot Number: 5269485
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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