BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes 367963Recalls & reported problems
Becton, Dickinson And Company · TUBE PST PLH 13X100 4.5 MLBL L/GN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Vacutainer PST lithium heparin blood collection tube is used to collect blood samples. Its 93 reports mostly describe foreign particles or contamination found in the tube, leaks and splashes, and tubes filling incorrectly. No deaths or injuries are reported. The device has 1 recall, from June 2019 and closed, over falsely high carboxyhemoglobin readings when samples are run on a specific instrument. Reports for the last 12 months (1) are fewer than in the previous 12 months (6).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 30382903679639), received between Oct 18, 2017 and Nov 12, 2025 — classified as 93 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (64 reports).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jun 12, 2019Class IITerminated
False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.
Z-2304-2019 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material64
- Leak/Splash18
- Material Deformation8
- Incorrect, Inadequate or Imprecise Result or Readings7
- Short Fill5
- Device Markings/Labelling Problem4
- Fluid/Blood Leak3
- Break2
Patient problems
- No Known Impact Or Consequence To Patient54
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient8
- No Patient Involvement5
- No Information2
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Break; Break
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES, THE HEMOGARD CAP WAS BROKEN IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23538578 ↗MalfunctionAug 18, 2025Premature Separation; Premature Separation
IT WAS REPORTED AFTER USING BD VACUTAINER® PST¿ LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE STOPPER CREPT OUT IN ONE (1) TUBE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835708 ↗MalfunctionJul 14, 2025Short Fill; Short Fill
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES, ONE (1) TUBE UNDERFILLED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22502324 ↗MalfunctionMay 15, 2025Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES, THERE WAS 1 TUBE WITH A DISFIGURED HEMOGARD CAP. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028165 ↗MalfunctionMay 15, 2025Short Fill; Material Deformation; Short Fill; Material Deformation
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES, THERE WAS 1 STOPPER WITH DEFECTIVE MOLDING THAT CAUSED THE TUBE TO UNDERFILL DURING BLOOD COLLECTION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027424 ↗MalfunctionFeb 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES FOREIGN MATTER-BLUISH IMPURITIES WAS FOUND FLOATING IN THE PLASMA. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21425663 ↗MalfunctionJan 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED AFTER USING AN UNSPECIFIED NUMBER OF BD VACUTAINER® PST¿ LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, FOREIGN MATTER WHITE IMPURITIES WERE FLOATING IN THE PLASMA. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21148093 ↗MalfunctionMar 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD WHITE FOREIGN MATTER IN THE TUBE WALL BEFORE AND AFTER CENTRIFUGATION. THERE WERE 30 TUBES AFFECTED. NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18915097 ↗MalfunctionOct 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BEFORE USE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD FOREIGN MATTER FOUND BETWEEN THE PACKAGE FILM AND THE BLOOD COLLECTION TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT A HAIR-LIKE FOREIGN MATTER WAS FOUND BETWEEN THE PACKAGE FILM AND THE BLOOD COLLECTION TUBE. FOREIGN MATTER WAS DETECTED BY VISUAL INSPECTION BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17943737 ↗MalfunctionSep 28, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH 5 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES FIBRIN CLOTS WERE DISCOVERED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DEFECT: AFTER CENTRIFUGATION, FIBRIN FILAMENTS WERE FOUND IN THE BLOOD COLLECTION TUBE. QUANTITY: 5. IMPACT: NO OTHER ADVERSE EFFECTS ON PATIENTS OR MEDICAL STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17839466 ↗MalfunctionJan 19, 2023Coagulation in Device or Device Ingredient; Device Ingredient or Reagent Problem; Coagulation in Device or Device Ingredient; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PLASMA IN TUBES APPEARS TO HAVE FIBRIN CLOTS.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200730 ↗MalfunctionJun 15, 2022Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THIS ADDITIVE ABNORMALITY AND SAMPLE QUALITY EVENTS OCCURRED 5 TIMES EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PST TUBE IS CLOTTING. POTENTIALLY NO HEPARIN IN THE TUBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14705077 ↗MalfunctionFeb 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS A BROKEN LID/CAP/HEMOGARD SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER STOPPER WAS ASSEMBLED INCORRECTLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13455637 ↗MalfunctionJan 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE HAS BEEN FOUND WITH A BROKEN CAP. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DEFECTIVE CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13206281 ↗MalfunctionDec 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FOREIGN MATTER WAS FOUND INSIDE THE TUBE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13027592 ↗MalfunctionSep 27, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE FOLLOWING ISSUE WAS FOUND IN TUBE: FM IN GEL X3."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533106 ↗MalfunctionAug 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS HEMOLYSIS. THIS EVENT OCCURRED 20 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE EXPERIENCED "HEMOLYSIS WITH TUBE 367963."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12281365 ↗MalfunctionJul 16, 2021Fluid/Blood Leak; Device Contamination with Chemical or Other Material; Fluid/Blood Leak; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL AND CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE FOLLOWING ISSUES WERE FOUND IN TUBES: FOREIGN MATTER IN THE GEL X5 AND DAMAGED TUBES X2."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12181145 ↗MalfunctionJun 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE FOLLOWING ISSUE WAS FOUND WITH THE TUBE: FOREIGN MATTER IN THE GEL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12070510 ↗MalfunctionJun 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THIS EVENT OCCURRED 2700 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FALSE POSITIVE RESULT ON RPR TEST. THEY ARE TESTING RPR TEST WITH SEIKISUI RPR REAGENT IN AU5800 OF BECKMAN COULTER. AND THERE WERE 100% FALSE POSITIVE RESULT WHEN RPR WERE TESTED WITH PLASMA (SERUM TESTED RESULTES WERE NEGATIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12053893 ↗MalfunctionMay 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE FOLLOWING ISSUE WAS FOUND IN TUBES: FOREIGN MATTER IN THE GEL X5."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11860659 ↗MalfunctionApr 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS A BROKE LID/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE CAP OF ONE TUBE WAS DEFORMED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11749590 ↗MalfunctionApr 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS A BLACK FOREIGN MATTER FOUND IN THE GEL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11749588 ↗MalfunctionApr 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: FOREIGN MATTER IN GEL X4; DIRTY CAP X 1; SPOT IN TUBE X2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11608679 ↗MalfunctionFeb 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 19 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOLLOWING ISSUES WERE FOUND IN TUBES (367963) FROM LOT 0258353: FM IN GEL ×12, DAMAGED TUBE ×2, DIRTY CAP ×2, DIRTY TUBE ×3".
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11375979 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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