BD SmartSite 10013364Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885403221927), received between Aug 29, 2018 and Mar 1, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE SECONDARY SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT MEDICATION STARTED LEAKING FROM THE BLUE LUER LOCK. NO ADVERSE EVENTS, HAPPENED BEFORE ADMINISTERING TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13639996 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SNAPPED OFF BELOW THE DRIP CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER SECONDARY TUBING SET THAT SNAPPED BELOW THE DRIP CHAMBER ON YAWKEY 8E. TUBING SNAPPED WHEN THE RN LIFTED THE MEDICATION OUT OF THE OUTER BAG DISPENSED BY PHARMACY. TO MY KNOWLEDGE THIS IS THE FIRST SET THAT HAS MALFUNCTIONED SINCE WE HAD ISSUES IN SEPTEMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857526 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SNAPPED OFF BELOW THE DRIP CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER SECONDARY TUBING SET THAT SNAPPED BELOW THE DRIP CHAMBER ON YAWKEY 8E. TUBING SNAPPED WHEN THE RN LIFTED THE MEDICATION OUT OF THE OUTER BAG DISPENSED BY PHARMACY... TO MY KNOWLEDGE THIS IS THE FIRST SET THAT HAS MALFUNCTIONED SINCE WE HAD ISSUES IN (B)(6)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857397 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SNAPPED OFF BELOW THE DRIP CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER SECONDARY TUBING SET THAT SNAPPED BELOW THE DRIP CHAMBER ON YAWKEY 8E. TUBING SNAPPED WHEN THE RN LIFTED THE MEDICATION OUT OF THE OUTER BAG DISPENSED BY PHARMACY... TO MY KNOWLEDGE THIS IS THE FIRST SET THAT HAS MALFUNCTIONED SINCE WE HAD ISSUES IN SEPTEMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857392 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SNAPPED OFF BELOW THE DRIP CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 6TH OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER SECONDARY TUBING SET THAT SNAPPED BELOW THE DRIP CHAMBER ON YAWKEY 8E. TUBING SNAPPED WHEN THE RN LIFTED THE MEDICATION OUT OF THE OUTER BAG DISPENSED BY PHARMACY... TO MY KNOWLEDGE THIS IS THE FIRST SET THAT HAS MALFUNCTIONED SINCE WE HAD ISSUES IN SEPTEMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857380 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SNAPPED OFF BELOW THE DRIP CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 7TH OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER SECONDARY TUBING SET THAT SNAPPED BELOW THE DRIP CHAMBER ON YAWKEY 8E. TUBING SNAPPED WHEN THE RN LIFTED THE MEDICATION OUT OF THE OUTER BAG DISPENSED BY PHARMACY... TO MY KNOWLEDGE THIS IS THE FIRST SET THAT HAS MALFUNCTIONED SINCE WE HAD ISSUES IN SEPTEMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857366 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ (B)(6) SECONDARY SET TUBING SNAPPED OFF BELOW THE DRIP CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER SECONDARY TUBING SET THAT SNAPPED BELOW THE DRIP CHAMBER ON YAWKEY 8E. TUBING SNAPPED WHEN THE RN LIFTED THE MEDICATION OUT OF THE OUTER BAG DISPENSED BY PHARMACY TO MY KNOWLEDGE THIS IS THE FIRST SET THAT HAS MALFUNCTIONED SINCE WE HAD ISSUES IN SEPTEMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857365 ↗
• MalfunctionNov 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SNAPPED OFF BELOW THE DRIP CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 7 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD ANOTHER SECONDARY TUBING SET THAT SNAPPED BELOW THE DRIP CHAMBER ON YAWKEY 8E. TUBING SNAPPED WHEN THE RN LIFTED THE MEDICATION OUT OF THE OUTER BAG DISPENSED BY PHARMACY... TO MY KNOWLEDGE THIS IS THE FIRST SET THAT HAS MALFUNCTIONED SINCE WE HAD ISSUES IN SEPTEMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857360 ↗
• MalfunctionNov 19, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SEPARATED FROM THE CHEMOTHERAPY CHAMBER AND LEAKED CHEMO ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SO I WENT TO THE PICU TODAY TO DO ANATOLIY CHEMO. AS I WAS BACK PRIMING I COULD HEAR SOMETHING SPILLING. THE TUBING CAME ABOUT FROM THE CHEMO CHAMBER AND CHEMO WAS SPILLING ONTO THE FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844533 ↗
• MalfunctionNov 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SNAPPED OFF AND STARTED LEAKING CHEMOTHERAPY MEDICINE AFTER BEING PREPARED FOR USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CHEMO WAS PREPARED IN PHARMACY AND APPROVED TO GO TO ADMINISTRATION. WHILE IN THE BAG THE TUBING SNAPPED OFF AND STARTED LEAKING IN THE BAG. THEY NOTICED IT BEFORE IT WENT OUT TO THE FLOOR. THIS IS NOW THE SECOND TIME IN THE LAST 6 DAYS, AND SEVERAL OF MANY TO HAPPEN TO THIS ACCOUNT. WE HAVE IMPLEMENTED AN INSPECTION OF EVERY TUBING SET TO ENSURE IT IS NOT KINKED BEFORE AS WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829168 ↗
• MalfunctionNov 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ SECONDARY SET TUBING SEPARATED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HAD ANOTHER TUBING SET 10013364 SNAP OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790663 ↗
• MalfunctionNov 3, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BD ALARIS SMARTSITE SECONDARY SET WAS DAMAGED, CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE NURSE ARRIVED AT THE BEDSIDE, ANOTHER NURSE, WHO HAD GONE TO ASSIST THE PATIENT PRIOR TO THE FIRST NURSE'S ARRIVAL, WAS FOUND TO BE HOLDING OXALIPLATIN BAG THAT HAD BEEN SEVERED FROM THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745684 ↗
• MalfunctionOct 15, 2021Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

  IT WAS REPORTED THAT 3 BD ALARIS¿ SMARTSITE¿ SECONDARY SETS' TUBING SEPARATED AND LEAKED CHEMO DURING USE, AND 3 SETS HAD KINKED TUBING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AT LEAST 3 DOCUMENTED OF THE TUBING SNAPPING OFF AND LEADING TO SIGNIFICANT SPILLS OF CHEMO. NOTICING KINKS IN THE TUBING AT THE CHAMBER SITE AND HAVE BEEN MANUALLY UNTWISTING THEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637941 ↗
• MalfunctionOct 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED 4 SEC W/SS DC 20DP & HANGER TEX HAD ISSUES WITH COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE¿VE BEEN SEEING AN INCREASED FREQUENCY OF LEAKS DUE TO THE TUBING THAT ATTACHES AT THE BOTTOM OF THE DRIP CHAMBER COMING FREE ENTIRELY. IT LOOKS LIKE THE SONIC WELDS OR WHATEVER MEANS OF ATTACHMENT BEING USED IS FAILING AT A HIGHER THAN USUAL RATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629368 ↗
• MalfunctionApr 17, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 17 SEC W/SS DC 20DP & HANGERS EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE ARE PARTICLES IN PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971822 ↗
• MalfunctionApr 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 17 SEC W/SS DC 20DP & HANGERS EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE ARE PARTICLES IN PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941456 ↗
• MalfunctionAug 29, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE INFORMATION RECEIVED SUGGESTS THAT THE INFUSION RATE WAS SLOWER THAN EXPECTED. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827700 ↗