BD SmartSite 82115ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613203009577), received between Mar 8, 2021 and Jul 7, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 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.

• MalfunctionJul 7, 2021Disconnection; Leak/Splash; Disconnection; Leak/Splash

  IT WAS REPORTED THAT THE ADD-ON BURETTE SS VLV PS BALL VLV DISCONNECTED FROM THE DRIP CHAMBER BELOW THE TUBING CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CONNECTION BETWEEN THE BALL VALVE DRIP CHAMBER AND BECAME DISCONNECTED FROM THE TUBING BELOW THE CHAMBER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132527 ↗
• MalfunctionJun 23, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE ADD-ON BURETTE SS VLV PS BALL VLV IV PORT WAS BLOCKED/OCCLUDED AND RESULTED IN FLOW ISSUES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV PORT NOT WORKING, APPEARS TO BE BLOCKED OR FAULTY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054624 ↗
• MalfunctionJun 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE ADD-ON BURETTE SS VLV PS BALL VLV AFTER BEING HUNG AND LEAKED ANTIBIOTIC MEDICINE ONTO THE FLOOR. THIS OCCURRED 6 TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING FROM BASE OF BURETTE CAUSING ANTIBIOTIC TO DRIP ONTO THE FLOOR AND PATIENT TO RECEIVE INADEQUATE DOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936039 ↗
• MalfunctionJun 1, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE ADD-ON BURETTE SS VLV PS BALL VLV WAS BLOCKED AND HAD FLOW ISSUES WHILE INFUSING THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE INJECTION PORT OF THE BURETTE WAS NOT WORKING PROPERLY. THE NURSE TRY TO ADD/INJECT MEDICATION INTO THE BURETTE BUT THE MEDICATION COULD NOT BE PUSHED INTO THE SYSTEM. NURSE TRIED MANIPULATING THE CLAMPS ETC BUT MADE NO DIFFERENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918078 ↗
• MalfunctionMar 8, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 ADD-ON BURETTE SS VLV PS BALL VLV LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "FAULT WITH 2 BURETTES THE PROBLEM APPEARS TO BE SIMILAR. BURETTE 1 - LEAKED WHEN AIR INLET CLOSED OR OPENED, ALSO WHEN TRYING TO REFILL BURETTE. WHEN ON CONTINUOUS INFUSION WITH AIR INLET CLOSED BURETTE FILLED AND THEN LEAKED OUT THE MEDICATION PORT. BURETTE 2 - SET PRIMED AIR INLET CLOSED (PLACED IN ALARIS PUMP) LEFT STANDING FOR 1-2 HOURS AWAITING NEW ADMISSION, LATER FOUND BURETTE FILLED AND LEAKING FROM AIR INLET AND MEDICATION PORT AND BOTTOM OF BURETTE. UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441175 ↗
• MalfunctionMar 8, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT ADD-ON BURETTE SS VLV PS BALL VLV HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO ADD MEDICATION TO THE BURETTE USING THE MEDICATION PORT. DIFFERENT SYRINGES USED WITH SAME RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11441154 ↗