SafeDAY™ 362006Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046964293979), received between Feb 15, 2018 and Feb 15, 2018 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275737 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275735 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 6: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275733 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 7: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275732 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 8: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275731 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 5: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275729 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 4: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275728 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS, THAT THERE IS AN ONGOING ISSUE WITH THE IV TUBING. WHEN THE TUBING IS FIRST OPENED, THE CONNECTION AT THE STOPCOCK IS ALWAYS LOOSE TO THE POINT WHERE THE TUBING COMES APART DURING PRIMING, UNLESS YOU AGGRESSIVELY TIGHTEN IT AT THE STOPCOCK. THE STAFF WAS EDUCATED TO MAKE SURE IT WAS TIGHTENED PRIOR TO PRIMING TO ADDRESS THE CONCERN. IN THE LAST FEW WEEKS, MULTIPLE INCIDENTS OCCURRED WHERE THE TUBING SEPARATES AFTER THE IV WAS STARTED, RESULTING IN BLOOD BACK FLOWING AND LEAKING OUT OF THE TUBING AND ALL OVER THE FLOOR. THIS OCCURRED EVEN THOUGH THE CONNECTION WAS TIGHTENED AT THE STOPCOCK. NO CHEMO INVOLVED AS THEY ARE AN ENDOSCOPY CENTER GENERAL IV SOLUTION INFUSING. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275727 ↗