BD Vacutainer® PST™ Gel & Lithium HeparinN (LH) 56 Units Blood Collection Tubes 368056Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 30382903680567), received between Apr 17, 2018 and Jul 15, 2022 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (12 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.

Recalls naming this device

1. 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-2307-2019 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2022Separation Problem; Separation Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES WHILE CUSTOMER WERE DRAWING 2 PATIENTS, THE TUBE POPPED IMMEDIATELY OFF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES DRAW 2 PATIENTS USING THE GREEN TIGER TOPS, PRODUCT 368056 ON LOT 1288747, AND BOTH TIMES THE TUBES POPPED IMMEDIATELY OFF THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029095 ↗
• MalfunctionFeb 24, 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 THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT THERE WAS A GEL SEPARATION ISSUE. 1 OR 2 TUBES WERE DRAWN ON OTHER DATES, BUT WERE NOT SAVED, ONE TUBE DID HAVE THE GEL ABOVE THE PLASMA AND CELLS. WE WERE NOT ABLE TO CENTRIFUGE THE GEL DOWN AFTER THE INITIAL CENTRIFUGATION. POOR BARRIER APPEARS OCCASIONALLY. TUBES ARE KEPT AT ROOM TEMPERATURE AND MOST TUBES KEPT UPRIGHT TIL CENTRIFUGED. ADDITIONAL INFORMATION: (B)(6) 2021: CUSTOMER STATES "UNFORTUNATELY WE DIDN'T NOTICE THE DRAW VOLUME ON THE TUBES. WE INITIALLY THOUGHT THE FIRST 1-2 WERE RELATED TO PATIENT'S CONDITION. THE PROTEINS IF I REMEMBER CORRECTLY WERE NOT ELEVATED, LIKE YOU MIGHT FIND IN MULTIPLE MYELOMA."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11375945 ↗
• MalfunctionNov 20, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "THAT TWO PCS WERE FOUND WITHOUT LABEL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10877744 ↗
• MalfunctionNov 3, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE TUBE IS UNDER-FILLING."

  Patient problems: No Patient Involvement

  MAUDE report 10782185 ↗
• MalfunctionOct 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES EXPERIENCED DISCOLORED/ABNORMAL ADDITIVE FORM. THIS EVENT OCCURRED 22 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THAT TWENTY TWO SAMPLES WERE SPUN AND THE SAMPLE APPEARED CLOUDY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10692081 ↗
• MalfunctionSep 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BEFORE USE THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 6 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER "WITNESSED BLACK CHUNKS IN VACUTAINER."

  Patient problems: No Patient Involvement

  MAUDE report 10549145 ↗
• MalfunctionSep 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED IN TUBES WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THIS OCCURRED WITH 2 TUBES FROM LOT# 0072540 PRIOR TO USE, AND 1 TUBE WITH LOT# 0100294 AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER WITNESSED UNKNOWN FOREIGN BLACK MATTER IN TUBES; AFTER AND BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 10532680 ↗
• MalfunctionApr 13, 2020Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT VACUTAINER ARE UNDER FILLING WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THIS OCCURRED ON 50 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER IS EXPERIENCING UNDER FILLING WITH VACUTAINERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9954452 ↗
• MalfunctionMar 10, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE ERRONEOUS RESULTS WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS ISSUES RELATED TO THE GEL AND DRUG INTERACTIONS WITH THERAPEUTIC DRUG MONITORING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9812318 ↗
• MalfunctionJan 6, 2020Coagulation in Device or Device Ingredient; Incorrect Measurement; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Coagulation in Device or Device Ingredient; Incorrect Measurement; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED AFTER USE WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER THEY EXPERIENCED AN FALSE-POSITIVE HCG (14.0) RESULT, BARRIER SEPARATION, HEMOLYSIS AND CLOTTING. CUSTOMER HAS EXPERIENCED SEVERAL OCCURRENCES OF POOR BARRIER SEPARATION, ERRONEOUS RESULTS, HEMOLYSIS AND CLOTTING WHEN USING PRODUCT 367961, LOT 9220493. SHE HAS SENT IN PHOTO TO BD COMPLAINT TEAM INBOX. NO SPECIFIC DATE OF EVENT OR OCCURRENCES. THE RESULTS NOTED IN SECTION WAS WHAT SHE COULD REMEMBER. NO PATIENT IDENTIFIERS WILL BE GIVEN, SAMPLES ARE AVAILABLE. SHE WOULD LIKE TECH SUPPORT AS TO WHAT IS CAUSING THIS. CUSTOMER STATED ONE PATIENT'S SURGICAL PROCEDURE WAS POSTPONED DUE TO AN ERRONEOUS RESULT. THOUGH SHE DID NOT KNOW WHAT SPECIFIC TEST, RESULT OR PATIENT. COMMENT TYPE: WORK PERFORMED SHE STATES THAT THE SMEAR NEAR THE TOP OF THE PLASMA LAYER IS GEL. THE MIDDLE PICTURE SHOW A RED CELL CLOT ON THE WASH AREA AND THE BOTTOM PICTURE SHOWS A MASS THAT DRIPPED ONTO THE INSTRUMENT. THIS IS HAPPENING WITH TUBE FROM BOTH IN PATIENT AND OUT PATIENT AREAS. THEY CURR

  Patient problems: Test Result

  MAUDE report 9555105 ↗
• MalfunctionDec 31, 2019Coagulation in Device or Device Ingredient; Incorrect Measurement; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Coagulation in Device or Device Ingredient; Incorrect Measurement; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES EXPERIENCED ERRONEOUS RESULTS, OIL GEL GLOBULES, HEMOLYSIS, POOR BARRIER SEPARATION, CLOTTING/MICRO CLOTS/FIBRIN CLOTS, CLOGGED/BLOCKED INSTRUMENTATION PROBE. PRODUCT DEFECTS WERE NOTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367961, BATCH NO. 9220493. COMPLAINT 2 OF 4. IT IS REPORTED BY CUSTOMER HER FACILITY EXPERIENCED AN ERRONEOUS RESULT OF CRITICALLY HIGH SODIUM RESULTS, BARRIER SEPARATION, AND CLOTTING. CUSTOMER HAS EXPERIENCED SEVERAL OCCURRENCES OF POOR BARRIER SEPARATION, ERRONEOUS RESULTS, OIL GEL GLOBULES AND CLOTTING WHEN USING PRODUCT 367961, LOT 9220493. NO SPECIFIC DATE OF EVENT OR OCCURRENCES. THE RESULTS NOTED IN SECTION WAS WHAT SHE COULD REMEMBER. NO PATIENT IDENTIFIERS WILL BE GIVEN. CUSTOMER STATED ONE PATIENT'S SURGICAL PROCEDURE WAS POSTPONED DUE TO AN ERRONEOUS RESULT. THOUGH SHE DID NOT KNOW WHAT SPECIFIC TEST, RESULT OR PATIENT. THIS IS HAPPENING WITH TUBE FROM BOTH IN PATIENT AND OUT PATIENT AREAS. THEY CURRENTLY SPIN AT 1912 G OR 3000RPM FOR 6 MINUTES. THIS PARTICULATE MATTER IS CLO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9534178 ↗
• MalfunctionDec 27, 2019Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings; Coagulation in Device or Device Ingredient; Incorrect, Inadequate or Imprecise Result or Readings

  IT IS REPORTED THAT THE THERE WERE ERRONEOUS RESULTS, HEMOLYSIS, BARRIER SEPARATION, GEL GLOBULES, AND CLOTTING WHEN USING A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 4 COMPLAINTS) CUSTOMER HAS EXPERIENCED SEVERAL OCCURRENCES OF POOR BARRIER SEPARATION, ERRONEOUS RESULTS, OIL GEL GLOBULES AND CLOTTING WHEN USING PRODUCT 367961, LOT 9220493.NO SPECIFIC DATE OF EVENT OR OCCURRENCES.NO PATIENT IDENTIFIERS WILL BE GIVEN, SAMPLES ARE AVAILABLE. SHE WOULD LIKE TECH SUPPORT AS TO WHAT IS CAUSING THIS. CUSTOMER STATED ONE PATIENT'S SURGICAL PROCEDURE WAS POSTPONED DUE TO AN ERRONEOUS RESULT. THOUGH SHE DID NOT KNOW WHAT SPECIFIC TEST, RESULT OR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527989 ↗
• InjuryDec 27, 2019Coagulation in Device or Device Ingredient; Incorrect Measurement; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; Coagulation in Device or Device Ingredient; Incorrect Measurement; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE HAD A GEL SMEAR NEAR THE TOP OF THE PLASMA LAYER. ANOTHER TUBE HAD A RED BLOOD CELL CLOT ON THE WASH AREA, AND ANOTHER DRIPPED A "MASS" ONTO THE INSTRUMENT. THIS PARTICULATE MATTER CLOGGED THE INSTRUMENTATION PROBES, CAUSING ISSUES AND ERRONEOUS RESULTS. ALL ISSUES HAPPENED AFTER USE. THE TUBES WERE SPUN AT "1912 G OR 3000RPM FOR 6 MINUTES", AND ALLOWING THE SPECIMENS TO SIT PRODUCED "NORMAL" RESULTS. ADDITIONALLY, IT WAS REPORTED THAT A PATIENT WITH "NA" AT "115" AND "HCG 106" WAS SENT TO THE ER, BUT DRAWING BLOOD PRODUCED "NORMAL" RESULTS AND "HCG" WAS FOUND "NEGATIVE". "HCG AND TROPONIN" WERE THE "MOST AFFECTED" VALUES OF RESULTS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBE FROM AN OUTREACH FACILITY HAS A SMEAR NEAR THE TOP OF THE PLASMA LAYER, WHICH IS GEL. ANOTHER HAS A RED CELL CLOT ON THE WASH AREA, AND THERE IS A MASS THAT DRIPPED ONTO THE INSTRUMENT. THIS IS HAPPENING WITH TUBES FROM BOTH IN PATIENT AND OUT PATIENT AREAS. THEY CURRENTLY SPIN AT 1912 G OR 3000RPM FOR 6 MINUTES

  Patient problems: Test Result

  MAUDE report 9526305 ↗
• MalfunctionSep 27, 2019Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THAT DURING USE THE TUBE WAS UNDER FILLING WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN FRANKLIN LAKES, WE ENCOUNTERED 1 TUBE THAT DID NOT FILL DURING TESTING. THE CATALOG NUMBER & BATCH INFORMATION IS: CATALOG#: 367961, BATCH#: 9126525, TEST DATE: 12 SEPT 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9128938 ↗
• MalfunctionAug 29, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT POOR SEPARATION OCCURRED AFTER USE WITH A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 56 UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THERE ARE ISSUES WHEN CENTRIFUGING GEL TUBES IN A REFRIGERATED CENTRIFUGE." 10 OCCURRENCES WERE REPORTED, BUT THE DATES/TIMES WERE NOT GIVEN.

  Patient problems: No Patient Involvement

  MAUDE report 8947389 ↗
• MalfunctionAug 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING HEMOLYSIS AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367961 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THERE'S A HIGH PERCENTAGE OF HEMOLYSIS. SPOKE WITH THE CUSTOMER, AND PROVIDED 53 MM OF MERCURY FOR THE VACUUM PRESSURE FOR THESE TUBES. HE IS TRYING TO DETERMINE WHY THE ER IS HAVING SUCH A HIGH PERCENTAGE OF HEMOLYSIS COMPARED TO THE PHLEBOTOMISTS THAT USE THE SAME TUBES. I EXPLAINED THAT IN MOST ERS, THE NURSES DRAW BLOOD FROM AN IV VS A STRAIGHT NEEDLE OF WINGED SET USED BY THE PHLEBOTOMISTS. THEY HAVE DISCONTINUED USING 367961, AND ARE USING 367962. THE CURRENT LOT # IS 9095790. I REVIEWED THE COLLECTION PROCESS WITH HIM, AND SENT THE PST PROCESSING LITERATURE, AND THE LLAD LITERATURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931369 ↗
• MalfunctionMar 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 65 UNITS BLOOD COLLECTION TUBES WERE GIVING ERRONEOUS RESULTS. THIS OCCURRED ON 2 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO: 367961, BATCH NO: 8249563. IT WAS REPORTED WHEN THE TUBE WAS RAN ON AN ANALYZER IT CAME UP POSITIVE FOR EDTA, BUT AN EDTA TUBE WAS NOT DRAWN. TWO SAMPLES DRAWN OF BD ITEM #: 367961 WHEN RAN ON ANALYZER CAME UP POSITIVE FOR EDTA REMANENT BUT AN EDTA TUBE WAS NOT DRAWN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8453620 ↗
• MalfunctionMar 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES HAD HEMOLYSIS. THE FOLLOWING WAS REPORTED, "IT WAS REPORTED THE CUSTOMER EXPERIENCED HEMOLYSIS PROBLEMS INTERMITTENTLY. OVER THE YEARS, I HAVE ENCOUNTERED HEMOLYSIS PROBLEMS INTERMITTENTLY, AND RARELY, EVEN AFTER EDUCATION, A TECH MAY STILL HAVE A HIGH HEMOLYSIS RATE ON CHEMISTRY TUBES. WE NOTE IT MOST THERE BECAUSE OF ANALYTES HIGHLY SENSITIVE TO HEMOLYSIS SUCH AS K+, MG+, AST, ALT, LDH AND A FEW OTHERS. FROM 2008 TO 2012, THE HEMOLYSIS INDEX GIVEN BY THE MACHINES WAS ACCURATE AND COULD BE VERIFIED BY OTHER METHODOLOGY. NOT SO MUCH NOW. PLEASE TELL ME WHAT THE VACUUM PRESSURE IS FOR EACH OF THE FOLLOWING TUBES:"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400279 ↗
• InjuryJan 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH SPORADIC FALSE ELEVATED TROPONIN RESULTS ON 7 PATIENTS RESULTING IN REDRAWS.

  Patient problems: No Code Available

  MAUDE report 8271879 ↗
• MalfunctionDec 28, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH DEBRIS IN PLASMA SAMPLE. THERE WERE 5 OCCURRENCES REPORTED BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203308 ↗
• MalfunctionJun 13, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES HAD PROBLEMS WITH THE DRAW VOLUME. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7597747 ↗
• MalfunctionJun 13, 2018Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 56 UNITS BLOOD COLLECTION TUBES WERE MISSING THE STOPPER IN THE PACKAGE. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7596874 ↗
• MalfunctionJun 12, 2018Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES HAD MISSING STOPPERS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7594569 ↗
• MalfunctionJun 12, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES WERE NOT FILLING TO ACCEPTABLE LEVELS. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7593743 ↗
• MalfunctionJun 11, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HEMOLYSIS; CAUSED NO SERIOUS INJURY MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7588620 ↗