BD Vacutainer® Serum 366668Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 30382903666684), received between Dec 1, 2017 and Feb 12, 2025 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (21 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, THERE WAS POOR BARRIER SEPARATION SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367559 ↗
• MalfunctionApr 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN INTERNAL STUDY WAS CONDUCTED USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES WHICH INDICATED THAT THE ORIENTATION OF THE TUBE DURING CLOTTING HAD A SIGNIFICANT EFFECT ON THE LDH VALUE. TUBES CLOTTED UPSIDE DOWN HAD HIGHER LDH VALUES THAN TUBES CLOTTED RIGHT SIDE UP. 116 TUBES WERE STUDIED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133228 ↗
• MalfunctionMar 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, RED BLOOD CELLS WERE OBSERVED IN THE SERUM AFTER CENTRIFUGATION ON AN UNSPECIFIED AMOUNT OF TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18875904 ↗
• MalfunctionSep 7, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES ARE FREEZING IN THE REFRIGERATOR. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT SERUM SAMPLES ARE FREEZING IN REFRIGERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699899 ↗
• MalfunctionApr 20, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH 100 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THE ADDITIVE APPEARED TO BE ABNORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED ABNORMALITY WITH THE ADDITIVE COATING OF THE TUBES IN BOX THEY RECENTLY OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781771 ↗
• MalfunctionJul 8, 2022Short Fill; Defective Component; Device Ingredient or Reagent Problem; Short Fill; Defective Component; Device Ingredient or Reagent Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD, DISCOLORED/ABNORMAL ADDITIVE FORM AND DEFECTIVE COMPONENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE " TUBES HAVE AIR BUBBLES IN THEM THUS RESULTING IN ADDITIVE ABNORMALITY AND "NEGATIVE PRESSURE" WHICH IS RESULTING IN DRAW VOLUME. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959618 ↗
• MalfunctionMay 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES ELEVATED LDH VALUES WERE DISCOVERED DURING AN INTERNAL CLINICAL STUDY. THERE WAS NO IMPACT TO PATIENTS AND RESULTS WERE NOT REPORTED TO CLINICIANS. THIS EVENT OCCURRED 80 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE COMPLAINT STATED: "IN AN INTERNAL CLINICAL STUDY, (B)(6), IT WAS FOUND THAT THE VALUE FOR LDH WAS SIGNIFICANTLY LARGER WHEN THE TUBE CLOTTED IN AN UPSIDE DOWN VS RIGHT-SIDE UP ORIENTATION. THE LDH ISSUE WAS NOT SEEN IN OTHER TUBES IN THE SAME STUDY THAT WERE PROCESSED AND EXAMINED IN A SIMILAR FASHION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292957 ↗
• MalfunctionMar 31, 2022Contamination; Contamination

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED DISCOLORED/ABNORMAL ADDITIVE FORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES HAVE WATER MARKS ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13959787 ↗
• MalfunctionDec 14, 2021Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT WHEN CENTRIFUGING THE SERUM SEPARATES INTO A GEL LIKE CONSISTENCY AND THEY HAVE TO CENTRIFUGE IT AGAIN TO COMPLETE THE FULL SEPARATION. (B)(6): ON (B)(6) 2021 17:34:31 (GMT); REFERENCE (B)(4) FOR SAME COMPLAINT ON A DIFFERENT PRODUCT NUMBER. VERBATIM, "BLOOD COLLECTION W/ CATS AND DOGS, AND WHEN THEY GO TO SEPARATE THE TUBES, THE SERUM, AND SOME IT SEPARATES INTO A GEL LIKE CONSISTENCY, AND USUALLY THE CENTRIFUGE IT AGAIN AND IT COMPLETES THE FULL SEPARATION. WONDERING HOW TO GET IT TO SEPARATE THE FIRST TIME, THEY¿VE TRIED DIFFERENT TEMPERATURES/PLACING ON ICE/ETC, ALSO TRIED INCREASING CENTRIFUGE BEADS FROM 1300 TO 3000G". EVENT DATE: UNKNOWN - HAPPENING SINCE (B)(6); MATERIAL NO: 366668; LOT NO: UNKNOWN; QTY: UNKNOWN. BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX A - COMPLAINT DETERMINATION TREE ¿ ((B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005112 ↗
• MalfunctionMay 7, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER REPORTED "ABOUT UNDERFILL OF A TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791538 ↗
• MalfunctionMar 16, 2021Short Fill; Volume Accuracy Problem; Short Fill; Volume Accuracy Problem

  IT WAS REPORTED THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER CALLED IN TO REPORTED ISSUES OF UNDER-FILLING. SHE STATED THERE IS LITTLE TO NO VACUUM. NO DATE OF EVENT, NO SPECIFIC NUMBER OF OCCURRENCES, NO ERRONEOUS RESULTS AND NO MEDICAL INTERVENTION. CUSTOMER CONFIRMED UNUSED SAMPLES ARE AVAILABLE FOR INVESTIGATION. (B)(6), - "SPOKE WITH THE CUSTOMER. SHE STATED THAT ALL 35 TUBES IN THIS LOT HAVE HAD LITTLE OR NO VACUUM AT ALL, WHEN USING A STRAIGHT NEEDLE. THEY ARE NOW USING DIFFERENT LOT #S AND ARE NOT SEEING ANY VACUUM ISSUES. SHE WILL SEND IN SAMPLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499563 ↗
• MalfunctionJul 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USE 2 SAMPLES HAD HEMOLYSIS WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES HAD SLIGHT HEMOLYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10304959 ↗
• MalfunctionJun 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES EXPERIENCED HEMOLYSIS (E.G. BLOOD SAMPLE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED WHILE USING THE PRODUCT THE "SAMPLE HAD A HEMOLYSIS SITUATION." THE CUSTOMER STATES "THEY ARE USING THEIR OWN BLOOD COLLECTION NEEDLE TO COLLECT SAMPLES FROM THE CUBITAL VEIN. AFTER COLLECTION, BLOOD IS INVERTED 5-8 TIMES AND TRANSFERED TO CENTRIFUGE ROOM, THEN PLACED IN A SYMMETRICAL POSITION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203121 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD HEMOLYSIS (E.G. BLOOD SAMPLE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED "THERE IS HEMOLYSIS IN TUBES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 7 OF 13 RELATED INCIDENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10167898 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER USE, THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD HEMOLYSIS (E.G. BLOOD SAMPLE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED "THERE IS HEMOLYSIS IN TUBES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2 OF 13 RELATED INCIDENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10167895 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD HEMOLYSIS (E.G. BLOOD SAMPLE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED "THERE IS HEMOLYSIS IN TUBES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5 OF 13 RELATED INCIDENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10167887 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED AFTER USE THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES HAD HEMOLYSIS (E.G. BLOOD SAMPLE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED "THERE IS HEMOLYSIS IN TUBES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10167886 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HEMOLYSIS OCCURRED AFTER USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (12 OF 13 COMPLAINTS) IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBES. ADDITIONALLY, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID THE COURSE OF TREATMENT CHANGE? UK. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? NA. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? UK. WHAT SIZE NEEDLE GAUGE WAS USED? UK. HOW LONG DID IT TAKE TO FILL THE TUBES? UK. WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? NEEDLE. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? NA. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NA. WERE ALL COMPONENTS OF BLOOD COLLECTION EQUIPMENT COMPATIBLE (E.G., FIT TOGETHER SECURELY WITHOUT THE POSSIBILITY OF DRAWING AIR OR CAUSING FROTHING OF THE BLOOD)? NA. WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? UK. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPUNCTURE? UK WAS THERE ANY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10167454 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HEMOLYSIS OCCURRED AFTER USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (11 OF 13 COMPLAINTS) IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBES. ADDITIONALLY, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID THE COURSE OF TREATMENT CHANGE? NO. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? NO. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? UK. WHAT SIZE NEEDLE GAUGE WAS USED? UK. HOW LONG DID IT TAKE TO FILL THE TUBES? STANDARD WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? NEEDLE. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? NO. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NO. WERE ALL COMPONENTS OF BLOOD COLLECTION EQUIPMENT COMPATIBLE (E.G., FIT TOGETHER SECURELY WITHOUT THE POSSIBILITY OF DRAWING AIR OR CAUSING FROTHING OF THE BLOOD)? YES. WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? IODOPHOR DISINFECTION. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10167451 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HEMOLYSIS OCCURRED DURING USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (13 OF 13 COMPLAINTS) IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBES. ADDITIONALLY, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID THE COURSE OF TREATMENT CHANGE? NO. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? NO. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? NO. WHAT SIZE NEEDLE GAUGE WAS USED? UK. HOW LONG DID IT TAKE TO FILL THE TUBES? ~30SEC. WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? NO. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? UK. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NO. WERE ALL COMPONENTS OF BLOOD COLLECTION EQUIPMENT COMPATIBLE (E.G., FIT TOGETHER SECURELY WITHOUT THE POSSIBILITY OF DRAWING AIR OR CAUSING FROTHING OF THE BLOOD)? SOME ARE NOT CLOSED WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? YES. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPUNCTURE?

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10167449 ↗
• MalfunctionJun 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HEMOLYSIS OCCURRED AFTER USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (9 OF 13 COMPLAINTS) IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBES. ADDITIONALLY, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID THE COURSE OF TREATMENT CHANGE? NO. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? NO. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? UK. WHAT SIZE NEEDLE GAUGE WAS USED? UK. HOW LONG DID IT TAKE TO FILL THE TUBES? 1-3MIN. WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? NO. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? YES/UN. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NO. WERE ALL COMPONENTS OF BLOOD COLLECTION EQUIPMENT COMPATIBLE (E.G., FIT TOGETHER SECURELY WITHOUT THE POSSIBILITY OF DRAWING AIR OR CAUSING FROTHING OF THE BLOOD)? NO. WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? UK. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPUNCTURE? UK WAS THERE A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10167351 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS HEMOLYSIS IN TUBES AFTER USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (6 OF 13 COMPLAINTS) IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBES. ADDITIONALLY, CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID THE COURSE OF TREATMENT CHANGE? NO. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? UK. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? UK. WHAT SIZE NEEDLE GAUGE WAS USED? UN. HOW LONG DID IT TAKE TO FILL THE TUBES? 15 SECS. WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? NO. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? UN. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NO. WERE ALL COMPONENTS OF BLOOD COLLECTION EQUIPMENT COMPATIBLE (E.G., FIT TOGETHER SECURELY WITHOUT THE POSSIBILITY OF DRAWING AIR OR CAUSING FROTHING OF THE BLOOD)? UK. WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? IODOPHOR DISINFECTION. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165463 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT HEMOLYSIS OCCURRED AFTER USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (8 OF 13 COMPLAINTS). IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBES. ADDITIONALLY, THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID THE COURSE OF TREATMENT CHANGE? NO. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? NO. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? NO. WHAT SIZE NEEDLE GAUGE WAS USED? STANDARD. HOW LONG DID IT TAKE TO FILL THE TUBES? 1MIN. WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? NEEDLE. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? STANDARD. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NO. WERE ALL COMPONENTS OF BLOOD COLLECTION EQUIPMENT COMPATIBLE (E.G., FIT TOGETHER SECURELY WITHOUT THE POSSIBILITY OF DRAWING AIR OR CAUSING FROTHING OF THE BLOOD)? YES. WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? NO. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPUNCTURE? 30

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165457 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBE AFTER USE WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 13 COMPLAINTS) IT WAS REPORTED THAT THERE IS HEMOLYSIS IN TUBES. ADDITIONALLY, CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: OUR SITES HAVE CONCERNS ON SENDING THESE SAMPLES BACK. THEY ARE IN (B)(6) AND THEY FEEL AS IF THERE COULD BE ISSUES WITH EXPORTING DOCUMENTS. THEY ALSO NOTED FOR (B)(6) REQUIREMENT, IT IS IMPOSSIBLE TO EXPORT ANY SAMPLE WHICH ARE NOT APPROVED IN (B)(6) PERMISSION. QUESTION SITE#0118. DID THE COURSE OF TREATMENT CHANGE? NO. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? NO. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? UK. WHAT SIZE NEEDLE GAUGE WAS USED? STANDARD. HOW LONG DID IT TAKE TO FILL THE TUBES? STANDARD. WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? UK. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? YES. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NO. WERE ALL COMPONENTS OF BLOOD COLLECTION E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165454 ↗
• MalfunctionJun 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES EXPERIENCED HEMOLYSIS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 366668. BATCH NO. 9228350. COMPLAINT 10 OF 13. DID THE COURSE OF TREATMENT CHANGE? NO. ARE THERE ANY PATIENT IDENTIFIERS KNOWN? NO. WAS IT A DIFFICULT VENIPUNCTURE? NO. WAS THERE ANY ¿PROBING" AT THE VENIPUNCTURE SITE? NO. WHAT SIZE NEEDLE GAUGE WAS USED? STANDARD. HOW LONG DID IT TAKE TO FILL THE TUBES? WITHIN 1MIN. WAS THE BLOOD COLLECTED WITH A NEEDLE AND SYRINGE? NO. WAS THE BLOOD, IF TRANSFERRED FROM A SYRINGE, FORCED INTO THE TUBE? NO. WAS THE BLOOD COLLECTED THROUGH A CATHETER/IV? WHAT WAS THE GAUGE OF THE CATHETER? THROUGH A CATHETER/IV. WAS A DISCARD TUBE COLLECTED IF COLLECTING FROM A CATHETER OR IV LINE? NO. WERE ALL COMPONENTS OF BLOOD COLLECTION EQUIPMENT COMPATIBLE (E.G., FIT TOGETHER SECURELY WITHOUT THE POSSIBILITY OF DRAWING AIR OR CAUSING FROTHING OF THE BLOOD)? YES. WAS THE ANTISEPTIC USED TO CLEANSE THE SITE ALLOWED TO DRY BEFORE THE VENIPUNCTURE? YES. HOW LONG WAS THE TOURNIQUET LEFT ON THE ARM DURING VENIPUNCTURE? WITHIN 1MIN WAS THERE ANY MOISTURE PRESENT IN THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10160369 ↗