BD Vacutainer® PPT™ K2E 15.8 mg 362800Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 50382903628006), received between May 15, 2018 and Jul 17, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Short Fill” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024Short Fill; Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER PPT K2E 15.8 MG AN UNSPECIFIED NUMBER OF TUBES HAD A VACUUM ISSUE RESULTING IN UNDERFILLED TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767931 ↗
• MalfunctionJul 19, 2021Fluid/Blood Leak; Deformation Due to Compressive Stress; Fluid/Blood Leak; Deformation Due to Compressive Stress

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THERE WERE TUBE EXTENDERS WITH MOLDING DEFECTS THAT CAN BE USED. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES APPEAR COLLAPSED AT ONE SIDE OF THE TUBE AND WERE NOTICED BY THE PHLEBOTOMIST PRIOR TO TAKING BLOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189096 ↗
• MalfunctionFeb 22, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT A BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG PARTIALLY FILLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363209 ↗
• MalfunctionNov 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG THERE WAS AN ISSUE WITH FOREIGN MATTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101662 ↗
• MalfunctionNov 12, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG THERE WAS AN ISSUE WITH MISSING LABEL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8059945 ↗
• MalfunctionMay 15, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT SOME BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES K2E 15.8 MG WERE UNDER FILLING.

  Patient problems: No Information

  MAUDE report 7514886 ↗