BD Vacutainer® Sodium HeparinN (NH) 158 U.S.P. Units Blood Collection Tubes 366480Recalls & reported problems
Becton, Dickinson And Company · TUBE NAHEP GC 16X100 10.0 PLBL GN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
These are BD Vacutainer blood collection tubes with sodium heparin, used to draw blood samples that stay clot-free. The 28 reports mostly describe problems found before use — clumped, dried-out, or discolored additive settled at the bottom of the tube, plus inaccurate fill volumes and one case of glass cracking in a freezer. None describe deaths or injuries, and most note no effect on patients. There are no recalls naming this device.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 30382903664802), received between May 30, 2018 and Sep 11, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (8 reports).
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
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material8
- Incorrect, Inadequate or Imprecise Result or Readings7
- Device Ingredient or Reagent Problem4
- Coagulation in Device or Device Ingredient3
- Break2
- Leak/Splash2
- Short Fill2
- Volume Accuracy Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient4
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SODIUM HEPARINN (NH) 158 U.S.P. UNITS BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES CONTAIN ABNORMAL ADDITIVE FORM (DISC AT THE BOTTOM OF THE TUBE.). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026328 ↗MalfunctionMay 15, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SODIUM HEPARINN (NH) 158 U.S.P. UNITS BLOOD COLLECTION TUBES, THERE WAS AN ADDITIVE ABNORMALITY (CLUMPED) IN 200 TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22032183 ↗MalfunctionOct 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SODIUM HEPARINN (NH) 158 U.S.P. UNITS BLOOD COLLECTION TUBES; 90 TUBES HAD AN ABNORMAL ADDITIVE IN THE BOTTOM OF THE TUBE (WHITE SEDIMENT FORMED AT THE BOTTOM OF THE TUBE). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20463110 ↗MalfunctionMar 7, 2024Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT THE BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES HAD ABNORMAL ADDITIVE FORM BEFORE USE. THIS OCCURRED 240 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856656 ↗MalfunctionMar 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT PRIOR TO USE, 240 BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES HAD ABNORMAL ADDITIVE FORM. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18845564 ↗MalfunctionOct 17, 2023Break; Break
HOLD FOR CO 10.24. IT WAS REPORTED THAT DURING USE FOR A RESEARCH PROJECT WITH BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES THE GLASS TUBE BROKE WHEN STORED IN THE FREEZER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: I AM USING YOUR GLASS VACUTAINERS FOR MY RESEARCH PROJECT. WE HAVE HAD SOME ISSUES WITH THE GLASS CRACKING WHEN THE SAMPLES ARE STORED IN THE FREEZER. WE ARE USING THE 10ML TUBES AND FILLING THEM WITH 5ML OF BLOOD, AND THEN PUTTING THEM DIRECTLY INTO THE FREEZER. THE TUBES HAVE CRACKED IN BOTH -20°C AND -80°C. IT IS NOT AN OPTION FOR US TO SWITCH TO A PLASTIC PRODUCT DUE TO THE NATURE OF THE RESEARCH. PRODUCT INFORMATION: 366480 PLASMA TUBE, 143 USP UNITS OF SODIUM HEPARIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17950248 ↗MalfunctionMay 8, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
IT WAS REPORTED THAT PRIOR TO USE WITH 300 BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES THE ADDITIVE WAS DRIED OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DRIED OUT ADDITIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16892305 ↗MalfunctionJan 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER WITHIN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED VERY THIN COATING OF WHITE POWDER INSIDE THE TUBES AT THE VERY BOTTOM. CUSTOMER REPORTING A VERY THIN COATING OF WHITE POWDER INSIDE THE TUBES AT THE VERY BOTTOM. SHE SEES IT IN AN ENTIRE BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13389015 ↗MalfunctionJan 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES IT WAS REPORTED THAT THE BD VACUTAINER SODIUM HEPARIN TUBES HAD DEVELOPED A WHITE FILM THAT SETTLED IN THE BOTTOM OF THE TUBES. CUSTOMER IS INQUIRING IF THIS IS SODIUM IN POWDER FORM AND IF THEY ARE STILL OKAY TO USE OR IF THEY NEED TO BE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13316674 ↗MalfunctionAug 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) 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 WERE "PARTICLES FLOATING FROM THE CAP." WHEN THE TUBES ARE UPSIDE DOWN THEY SEE PARTICLES FLOATING FROM THE CAP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12333646 ↗MalfunctionAug 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED DISCOLORED / ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER REPORTS THAT THEY ARE USING THE SODIUM HEPARIN TUBES AND THEY NOTICED THAT THERE IS CRYSTALLIZATION AT THE BOTTOM OF THE TUBE. SHE SAID IT LOOKS LIKE A CONTACT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12284459 ↗MalfunctionJul 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBE THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "OUR LAB HAS BEEN USING BD HEPARIN BLOOD COLLECTION TUBES FOR A LARGE LONGITUDINAL HUMAN DONOR STUDY IN OUR LAB. WE RECENTLY SENT PLASMA SAMPLES OUT FOR BIOCHEMISTRY TESTING, AND RELATIVE TO THE SAMPLES WE COLLECTED IN 2018, THE SAMPLES FROM THIS YEAR HAVE HIGHLY ELEVATED SODIUM AND CHLORIDE LEVELS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12150662 ↗MalfunctionMay 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES APPEARED TO BE DISCOLORED OR HAD AN ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER WOULD LIKE TO KNOW IF TUBES CAN STILL BE USED AS THE ADDITIVE APPEARS CRYSTALIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11904801 ↗MalfunctionJan 7, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem
IT WAS REPORTED THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBE EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY ARE WITNESSING UNDER-FILLING. RECEIVED CALL FROM DISTRIBUTOR STATING THAT THEIR CUSTOMERS HAVE BEEN EXPERIENCING UNDER-FILLING FOR A WHILE. NO SPECIFIC DATE OF EVENTS. NO SPECIFIC LOT NUMBER. NO SPECIFIC NUMBER OF OCCURRENCES. NO SPECIFIC FACILITY. BLOOD COLLECTION NEEDLE USED IS UNKNOWN. TUBES WERE TOSSED OUT AND ANOTHER TUBE WAS FILLED DURING SAME BLOOD DRAW."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11135791 ↗MalfunctionDec 7, 2020Break; Break
IT WAS REPORTED THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES EXPERIENCED GLASS BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER EXPERIENCED "GLASS BREAKAGE DURING CENTRIFUGATION. TODAY WE EXPERIENCE AN ISSUE WITH A BD VACUTAINER SODIUM HEPARIN TUBE. A TOTAL OF 4 OF THE SAME BD TUBES WERE BEING CENTRIFUGED, 1/4 BROKE WHILE IN USE. THE CENTRIFUGE WAS PROPERLY BALANCED AT TIME OF USE." ADDITIONAL INFORMATION: CUSTOMER STATED THEY ARE SPINNING AT 2000 RCF FOR 20 MINUTES. THIS IS THE PROCEDURE WRITTEN IN THE STUDY. IT WAS EXPLAINED THAT THE MAXIMUM SPEED IS 1300 RCF FOR 10 MINUTES, AND THAT THE EXCESSIVE SPEED AND TIME MAY HAVE CAUSED THE TUBES TO BREAK. ALSO RECOMMENDED THAT THEIR CENTRIFUGE BE CALIBRATED. THERE WAS NO EXPOSURE, TESTS OR MEDICAL INTERVENTIONS THAT WERE NECESSARY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10960088 ↗MalfunctionSep 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT SEVERAL TRACE ELEMENTS LEACH OUT AT GREATER CONCENTRATIONS THAN CLAIMED IN IFU WITH A BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT IS REPORTED IN STUDY THAT TUBES HAVE ISSUES FOR A VARIETY OF ELEMENTS CLAIMED ON THE IFU. ADDITIONALLY, ON 2020-08-31 THE BD TECH PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: SPOKE TO CUSTOMER, - "INTERNAL POST-MARKETING SURVEILLANCE IDENTIFIED A CLINICAL BIOCHEMISTRY ARTICLE SAYING THAT A SPECIFIC LOT OF OUR ROYAL BLUE PLASTIC TRACE ELEMENT TUBES LEACHES OUT SEVERAL TRACE ELEMENTS AT CONCENTRATIONS GREATER THAN WE CLAIM, AND THAT OUR GLASS SODIUM HEPARIN TUBE ALSO LEACHES OUT TRACE ELEMENTS. I EMAILED MS. ROSA SAYING I REVIEWED THE ARTICLE, IDENTIFIED THE LOT NUMBER OF THE PLASTIC TUBE BUT COULD NOT VERIFY THE SAME SPECIFIC TRACE METALS SHE DID (ALTHOUGH SEVERAL TRACE METALS HAD BEEN REPORTED AS ELEVATED IN TABLE 2). I ALSO NOTED THAT TABLE 3 REPORTED 5 YEARS OF TESTING 6 DIFFERENT LOT NUMBERS OF BOTH THE PLASTIC TRACE METAL TUBE AND THE GLASS SODIUM HEPARIN TUBE, BUT DID NOT GIVE THE OTHER 5 LOT NUMBERS FOR PLASTIC, OR ANY LOT NU
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10551311 ↗MalfunctionMay 15, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DAMAGE / DEFECTS / FOREIGN MATTER WERE FOUND BEFORE USE WITH BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE HAVE DISCOVERED A BATCH OF HEPARIN TUBES THAT HAD A NUMBER OF MANUFACTURING DEFECTS. DATE OF AWARENESS: (B)(6) 2020 DEFECTS: CRACKED GLASS CANE (ONE TUBE); STOPPER DEFORMATION (ONE TUBE); STOPPER DEFORMATION WITH EMBEDDED FOREIGN MATTER (ONE TUBE)". 4 OCCURRENCES WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10061835 ↗MalfunctionFeb 19, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING INTERNAL TESTING FOREIGN MATTER (HAIR) WAS DISCOVERED IN TUBE WITH A BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING INTERNAL BD TESTING, A LARGE PIECE OF HAIR WAS NOTICED IN THE TUBE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9727314 ↗MalfunctionNov 13, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING ONE OCCURRENCE EACH OF A MISSING LABEL AND LABEL LIFT OFF BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A TUBE WAS FOUND WITHOUT A LABEL AND ONE WITH THE LABEL FOLDED. PER EMAIL: DURING TUBE INSPECTION FOR R&D TESTING ONE BD VACUTAINER TUBE WAS IDENTIFIED WITHOUT A LABEL & ONE WITH A FOLDED LABEL. THE PRODUCT INFORMATION IS: CATALOG #: 366480. BATCH #: 9095724. DATE IDENTIFIED: (B)(6) 2019.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9318662 ↗MalfunctionOct 22, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND IN THE BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBE BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED SHE RECEIVED THIS PRODUCT AND LOT TODAY (10/07/2019) THAT SEEMS TO HAVE A WHITE BIOLOGICAL FOREIGN MATTER AT THE BOTTOM OF SEVERAL TUBES. SHE ADMITTED THIS IS AFFECTING THE MAJORITY OF THE PACK RECEIVED BUT NO EXACT AMOUNT KNOWN."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9218704 ↗MalfunctionOct 22, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND IN THE BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBE BEFORE USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE ON THE PHONE SHE ALSO ADMITTED THE SAME OCCURRENCE HAPPENED WITH A PREVIOUS SHIPMENT (DATE UNKNOWN) OF MATERIAL NO. 366480, BATCH NO. 9036725 (2 OF 2). NO AMOUNT OF TUBES AFFECTED ARE KNOWN FOR THIS OCCURRENCE. JUST LIKE TODAY'S INSTANCE, INCIDENT WAS BEFORE USE THEREFORE NO ERRONEOUS RESULTS, NO MEDICAL INTERVENTION, NO SERIOUS INJURY, NO PATIENT IDENTIFIERS, NO DEATH, NO COURSE OF TREATMENT CHANGE, NO EXPOSURE TO BLOOD, NO NEEDLE STICK AND NO SAFETY ISSUE. CUSTOMER DID ADMIT TUBES WITH THIS LOT WERE SIMPLY DISCARDED WHEN WITNESSED TO HAVE FM IN THEM."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9218601 ↗MalfunctionAug 7, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES STOPPERS CAME OFF. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 366480 BATCH NO:8345532 IT WAS REPORTED THE STOPPERS COME OFF AFTER COLLECTION. STOPPERS COMING OUT AFTER COLLECTION, NOT SUCTIONING VERY WELL. LAST COUPLE WEEKS, FRIDAY MOST RECENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8870628 ↗MalfunctionMar 26, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient
IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES HAD MICRO CLOTS. THIS OCCURRED ON 3 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO. 366480, BATCH NO. 8099579. EMAIL RECEIVED INQUIRING ON AN COMPLAINT, STATING 3 OCCURENCES OF MICRO-CLOTTING IN NAHEP TUBE WERE OBSERVED. EMAIL STATED, - "HELLO, WE RECENTLY COLLECTED BLOOD FROM NORMAL HEALTHY DONORS INTO NAHEP VACUTAINER TUBES. WITHIN 30-60 MINUTES OF THE DRAW, THE CLIENT PICKS UP THE TUBES FOR THEIR RESEARCH. THE TUBES PROCESSED IN THE FIRST 12HRS WERE FINE, BUT AT 24 HOURS 2 OF THE 6 TUBES HAD SOME MICRO-CLOTTING AND AT 48 HOURS A 3RD TUBE HAD MICRO-CLOTTING. THE CLIENT CLAIMS THE TUBES WERE STORED AT ROOM TEMP ON A SLOW ROCKER. DO YOU HAVE ANY SUGGESTIONS AS TO WHY MICRO-CLOTTING WOULD OCCUR AT 24HRS AND 48HOURS? THANK YOU".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8453713 ↗MalfunctionDec 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES HAD A MILKY WHITE POWDER WITH A FILM OVER IT STUCK AT THE BOTTOM OF THE TUBES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8156038 ↗MalfunctionDec 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD VACUTAINER® SODIUM HEPARIN (NH) BLOOD COLLECTION TUBES HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8155211 ↗
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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
- 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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