Alaris, SmartSite 10011253Recalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing Needle-Free Valve (Detachable) 20 cm (8 in) · Class 2
All models of Alaris, SmartSite (160)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403233609), received between Jul 31, 2019 and Jun 16, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage3
- Infusion or Flow Problem2
- Restricted Flow rate2
- Connection Problem1
- Crack1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
MalfunctionJun 16, 2025Complete Blockage; Infusion or Flow Problem; Complete Blockage; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT IT IS NOT DRAWING BLOOD WHEN ATTACHING A VACUTAINER. THE CAP IS LOOSE/COMES OFF WHEN TAKING IT OUT OF THE PACKAGE. WITH THE EXTENSION NOT DRAWING BLOOD, THEY ARE HAVING TO STICK THE PATIENT MORE THAN ONE FOR BLOOD DRAWS. CAP COMES OFF EASILY AND A PATIENT BLED OUT FOR AN UNKNOWN PERIOD OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22214655 ↗MalfunctionNov 27, 2024Infusion or Flow Problem; Infusion or Flow Problem
MATERIAL # 10011253; BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY KEEP GETTING AN OCCLUSIONS ERROR WHEN USING WITH OUR BRACCO RB 82 GENERATOR AND MEDRAD INTEGO RADIOPHARMACEUTICAL DOSING SYSTEM ON JUST ABOUT EVERY PATIENT. VERBATIM: HI, NUCLEAR MEDICINE IS EXPERIENCING ISSUES WITH THE NEW BD SMART SITE EXTENSION SE (REF 10011253), WE KEEP GETTING AN OCCLUSIONS ERROR WHEN USING WITH OUR BRACCO RB 82 GENERATOR AND MEDRAD INTEGO RADIOPHARMACEUTICAL DOSING SYSTEM ON JUST ABOUT EVERY PATIENT. RESULTING IN HAVING TO REPLACE AND HOPS THAT THE REPLACEMENT WORKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798176 ↗MalfunctionDec 9, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT EXT SET SMALLBORE TBG W/SS DEHP FREE WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 10011253, BATCH / LOT#: 20056551. IT WAS REPORTED THAT FLUIDS CANNOT BE PUSHED THROUGH THE EXTENSION SETS. THE NEW SETS THAT HAVE BEEN DEPLOYED ARE HAVING THE SAME ISSUE WHERE YOU CANNOT PUSH FLUIDS THROUGH THE EXTENSION SET. I HAVE HAD MULTIPLE COMPLAINTS WITHIN THE LAST WEEK THAT THIS ISSUE IS STILL OCCURRING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10978714 ↗MalfunctionNov 17, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE EXT SET SMALLBORE TBG W/SS DEHP FREE WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10011253 BATCH NO: 20056551. THE NEW SETS THAT HAVE BEEN DEPLOYED AS A SUB FOR ITEM 20039E] ARE HAVING THE SAME ISSUE WHERE YOU CANNOT PUSH FLUIDS THROUGH THE EXTENSION SET. I HAVE HAD MULTIPLE COMPLAINTS WITHIN THE LAST WEEK THAT THIS ISSUE IS STILL OCCURRING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10856481 ↗MalfunctionJul 31, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE "T PIECE EXTENSION" THAT WAS USED ON THE PATIENTS ARTERIAL LINE WAS LEAKING. T PIECE WAS REPLACED WITH A NEW ONE AND INSPECTED. THERE WAS A CRACK NOTED ALONG THE PLASTIC WHERE THE EXTENSION PIECE WOULD CONNECT TO THE PRESSURE MONITORING TUBING.
Patient problems: No Information
MAUDE report 8846572 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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