Alaris, SmartSite 20035ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613203011990), received between Dec 7, 2020 and Oct 11, 2022 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionOct 11, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET TUBING WAS DEFECTIVE AND CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR NURSES ARE UNABLE TO FLUSH THEM AND UTILIZE THEM IN PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575448 ↗
• MalfunctionMar 10, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE 6 INCH HEP LOCK EXT SET WOULDN'T FLUSH DUE TO FLOW ISSUES/BLOCKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE SALINE FLUSH IS ATTACHED TO THE EXTENSION TUBING, YOU ARE UNABLE TO PUSH/FLUSH THE LINE. IN SOME CASES IF YOU LET IT SIT FOR A WHILE, GREATER THAN 5 MINUTES, THEN IT WILL BEGIN TO WORK. NOT SURE IF IT IS RELATED TO THE PRESSURE THAT IS PUT ON BLUE ACCORDION PART OF THE EXTENSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457089 ↗
• MalfunctionFeb 25, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 6 INCH HEP LOCK EXT SET WAS NOT FLUSHING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20035E, BATCH NO: 20056944. IT WAS REPORTED THAT THERE ARE ISSUES WITH THE IV EXTENSION SETS NOT FLUSHING. VERBATIM: SOME OF OUR DEPARTMENTS ARE EXPERIENCING PROBLEMS WITH BD # 20035E SMARTSITE EXTENSION TUBING (SMALLBORE). THEY REPORT: ¿WHEN THE SALINE FLUSH IS ATTACHED THE LINE WILL NOT FLUSH. THEY SAID IT IS NOT ENGAGING/DEPRESSING THE BLUE PIECE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11378956 ↗
• InjuryDec 7, 2020Backflow; Complete Blockage; Restricted Flow rate; Backflow; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT BLOOD BACKFLOWED IN THE 6 INCH HEP LOCK EXT SET WHEN ENGAGING THE CLAMP AND REMOVING THE SYRINGE, CAUSING THE TUBING TO BECOME OCCLUDED. THIS REPORTEDLY CAUSED "INFILTRATIONS (EXTRAVASATIONS)", PHLEBITIS, AND PAIN FROM THE PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BD SMARTSITE EXTENSION SET REF (B)(4) IS AN UNACCEPTABLE SUBSTITUTION FOR OUR CURRENT SMARTSITE EXTENSION REF (B)(4). THE RIGIDITY OF THE TUBING PUTS UNDO TORQUE ON THE INSERTION SITE IF THE TUBING NEEDS TO BE LOOPED AWAY FROM A PLACE OF FLEXION. THIS IS ALSO CAUSING LOCAL PHLEBITIS WHICH IS LEADING TO MORE INIFILTRATIONS. IF A PLACE OF FLEXION IS TO BE AVOIDED FINDING A SUITABLE VEIN TO PLACE THE IV BECOMES LIMITED. WHEN FLUSHING THE IV, ENGAGING THE CLAMP, AND REMOVING THE SYRINGE, BLOOD BACKS UP INTO THE TUBING CAUSING THE SITE TO BECOME OCCLUDED. WE ARE SEEING MORE IV STARTS DUE TO OCCLUSIONS, INFILTRATIONS (EXTRAVASATIONS), AND PAIN VOICED FROM THE PATIENT."

  Patient problems: Vasculitis

  MAUDE report 10963798 ↗
• MalfunctionDec 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO 6 INCH HEP LOCK EXT SETS COULD NOT ASPIRATE OR WERE DIFFICULT TO DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 20035E, BATCH/ LOT #: 20076261. MANAGER FROM ER, LET ME KNOW HER STAFF PUT IN A VOICE ABOUT THE 6 INCH SET EXTENSION SUBS WE HAVE BEEN GETTING. THEY SAY THAT THESE ARE TOO STIFF AND DO NOT WORK AND PATIENTS ARE COMPLAINING ABOUT THEM AS WELL. SUBSTITUTION ITEM - SMART SITE EXTENSION SITE ARE TERRIBLE NOT FIRST TIME HAD DIFFICULTY W/ ITEM. TODAY, UNABLE TO DRAW BLOOD OFF SITE W/USE OF 2 DIFFERENT LUER LOCKS, THEN ATTEMPTED TO FLUSH EXTENSION TUBING W/SALINE TO SAVE IV SITE AND WOULD NOT FLUSH (IN MEAN TIME, PT BLEEDING ON FLOOR). ABLE TO ASK FOR ASSISTANCE OF ANOTHER STAFF MEMBER TO GET DIFFERENT EXTENSION SET, OTHER SUPPLIES NEEDED TO SAVE IV/GET LABS NEEDED WILL NOT USE THIS ITEM AGAIN UNLESS ABSOLUTELY NECESSARY AS EACH TIME HAVE HAD DIFFICULTY OF SOME KIND -PT C/O PAIN AS TUBING TO STIFF AND PULLS ON IV SITE, DIFFICULTY GETTING SYRINGE TO CONNECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10962352 ↗
• MalfunctionDec 7, 2020Complete Blockage; Restricted Flow rate; Leak/Splash; Complete Blockage; Restricted Flow rate; Leak/Splash

  IT WAS REPORTED THAT 6 INCH HEP LOCK EXT SET WOULD NOT FLUSH AND WAS DIFFICULT TO CONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1: MATERIAL #: 20035E BATCH/ LOT #: UNKNOWN IT WAS REPORTED THAT THE EXTENSION SET WOULD NOT FLUSH. EVENT 2: MATERIAL #: 20035E BATCH/ LOT #: UNKNOWN IT WAS REPORTED THAT THE SYRINGE WAS DIFFICULT TO CONNECT. NOT THE FIRST TIME HAD DIFFICULTY W/ITEM; TODAY UNABLE TO DRAW BLOOD OFF SITE W/USE OF 2 DIFFERENT LUER LOCKS, THEN ATTEMPTED TO FLUSH EXTENSION TUBING W/SALINE TO SAVE IV SITE AND WOULD NOT FLUSH (IN MEAN TIME, PT BLEEDING ON FLOOR); WILL NOT USE THIS ITEM AGAIN UNLESS ABSOLUTELY NECESSARY AS EACH TIME HAVE HAD DIFFICULTY OF SOME KIND -PT C/O PAIN AS TUBING TO STIFF AND PULLS ON IV SITE, DIFFICULTY GETTING SYRINGE TO CONNECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10959066 ↗