BD SmartSite C42010ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403230059), received between Sep 11, 2018 and Apr 4, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Disconnection; Disconnection

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE GRAVITY SET THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE FOUND THAT THEY (C42010E) ARE FALLING APART ONCE THE BAG IS SPIKED. OUR BIGGEST CONCERN WAS THE QUALITY OF THE TUBING STAYING TOGETHER, WE ARE SPENDING A LOT OF PRECIOUS TIME PUTTING LINES TOGETHER THAT CAN BE SPENT ON TAKING CARE OF PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678793 ↗
• MalfunctionOct 11, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED THE SET CAME APART DURING AN INFUSION IN THE OR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7957914 ↗
• MalfunctionSep 11, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED FOUR EVENTS WHERE THE IV SETS CAME APART, SOME DURING ADMINISTRATION. NO PATIENT HARM WAS REPORTED. THIS IS THE FILE FOR ONE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7867097 ↗
• MalfunctionSep 11, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED FOUR EVENTS WHERE THE IV SETS CAME APART, SOME DURING ADMINISTRATION. NO PATIENT HARM WAS REPORTED. THIS IS THE FILE FOR ONE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7867054 ↗
• MalfunctionSep 11, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED FOUR EVENTS WHERE THE IV SETS CAME APART, SOME DURING ADMINISTRATION. NO PATIENT HARM WAS REPORTED. THIS IS THE FILE FOR ONE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7867053 ↗
• MalfunctionSep 11, 2018Material Separation; Material Separation

  THE CUSTOMER REPORTED FOUR EVENTS WHERE THE IV SETS CAME APART, SOME DURING ADMINISTRATION. NO PATIENT HARM WAS REPORTED. THIS IS THE FILE FOR ONE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7867036 ↗