BD SmartSite 10014881Recalls & reported problems
BD Switzerland Sàrl · Low Sorbing Secondary Set, 79 cm (31 in) · Class 2
Quick summary
This BD SmartSite secondary IV set has 176 adverse event reports, with no deaths and no injuries. The reports mostly describe leaks at connections, tubing becoming blocked so fluid cannot pass, and sections separating, and some describe kinked or crimped tubing. No recalls name this device, and reports fell to 23 in the latest 12 months from 44 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 175
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 10885403221934), received between Jan 10, 2019 and Jul 10, 2026 — classified as 175 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (71 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash71
- Material Separation52
- Complete Blockage13
- Fluid/Blood Leak13
- Disconnection9
- Detachment of Device or Device Component7
- Break6
- Defective Component6
Patient problems
- No Clinical Signs, Symptoms or Conditions149
- Insufficient Information9
- No Consequences Or Impact To Patient8
- No Patient Involvement4
- Chemical Exposure3
- Burn(s)1
- No Information1
Recent adverse event reports
The 25 most recent of 175 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786567 ↗MalfunctionJun 9, 2026Leak/Splash; Material Separation
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BD ALARIS PUMP INFUSION SET'S TUBING MAY SEPARATE, LEAK, OR FAIL TO PRIME. WHEN THIS OCCURS: TREATMENT WILL BE DELAYED. THERE IS POTENTIAL FOR PATIENT BLOOD LOSS. THE COMPROMISED ADMINISTRATION SET PRESENTS A ROUTE FOR INFECTIOUS AGENTS. MEDICATION MAY SPILL, POTENTIALLY EXPOSING STAFF AND PATIENTS TO TOXIC MEDICATION (E.G., CHEMOTHERAPY AGENTS). ALSO, THE SPILL MAY PRESENT A FALL RISK. MEDICATION MAY BE WASTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449448 ↗MalfunctionMay 22, 2026Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO REPORT SEVERAL INCIDENTS WHERE THE DRUG IS NOW FLOWING THROUGH THE BD SMARTSITE LOW SORBING SECONDARY SET. REF 10014881.THE FLUID WILL PASS INTO THE DRIP CHAMBER BUT THEN IS UNABLE TO GO ANY FURTHER THROUGH THE TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CAN YOU CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED? THE ISSUE OCCURRED WITH BOTH PACLITAXEL AND DOCETAXEL. PLEASE CAN YOU CONFIRM IF THE MEDICATION WAS STORED IN THE REFRIGERATOR? IF YES, WAS IT ALLOWED TO REACH ROOM TEMPERATURE BEFORE USE? IT WAS IN THE FRIDGE BUT RETURNED TO ROOM TEMPERATURE BEFORE TRY TO ADMINISTER. PLEASE CAN YOU CONFIRM THE MAKE AND MODEL OF THE CONNECTING PRODUCTS? EQUASHIELD CLOSED SYSTEM SPIKE WAS ATTACHED TO BD SMARTSITE LOW SORBING SECONDARY SET. PLEASE CAN YOU CONFIRM IF THERE ARE ANY VISIBLE DEFECTS TO THE DEVICE I.E., CRACKS, FLASHES, KINKS? THERE DO NOT APPEAR TO BE ANY VISIBLE DEFECTS. PLEASE CAN YOU CONFIRM IF THE CONNECTING PRODUCT HAS A LUER SLIP OR LUER LOCK CONNECTION? LUER PLEASE CONFIRM WHETHER THE FLOW WA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25263190 ↗MalfunctionMay 22, 2026Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO REPORT SEVERAL INCIDENTS WHERE THE DRUG IS NOW FLOWING THROUGH THE BD SMARTSITE LOW SORBING SECONDARY SET. REF 10014881.THE FLUID WILL PASS INTO THE DRIP CHAMBER BUT THEN IS UNABLE TO GO ANY FURTHER THROUGH THE TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CAN YOU CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED? THE ISSUE OCCURRED WITH BOTH PACLITAXEL AND DOCETAXEL. PLEASE CAN YOU CONFIRM IF THE MEDICATION WAS STORED IN THE REFRIGERATOR? IF YES, WAS IT ALLOWED TO REACH ROOM TEMPERATURE BEFORE USE? IT WAS IN THE FRIDGE BUT RETURNED TO ROOM TEMPERATURE BEFORE TRY TO ADMINISTER. PLEASE CAN YOU CONFIRM THE MAKE AND MODEL OF THE CONNECTING PRODUCTS? EQUASHIELD CLOSED SYSTEM SPIKE WAS ATTACHED TO BD SMARTSITE LOW SORBING SECONDARY SET. PLEASE CAN YOU CONFIRM IF THERE ARE ANY VISIBLE DEFECTS TO THE DEVICE I.E., CRACKS, FLASHES, KINKS? THERE DO NOT APPEAR TO BE ANY VISIBLE DEFECTS. PLEASE CAN YOU CONFIRM IF THE CONNECTING PRODUCT HAS A LUER SLIP OR LUER LOCK CONNECTION? LUER. PLEASE CONFIRM WHETHER THE FLOW W
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25263189 ↗MalfunctionMay 22, 2026Complete Blockage
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM WRITING TO REPORT SEVERAL INCIDENTS WHERE THE DRUG IS NOW FLOWING THROUGH THE BD SMARTSITE LOW SORBING SECONDARY SET. REF 10014881.THE FLUID WILL PASS INTO THE DRIP CHAMBER BUT THEN IS UNABLE TO GO ANY FURTHER THROUGH THE TUBING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CAN YOU CONFIRM WHAT MEDICATION WAS BEING ADMINISTERED? THE ISSUE OCCURRED WITH BOTH PACLITAXEL AND DOCETAXEL. PLEASE CAN YOU CONFIRM IF THE MEDICATION WAS STORED IN THE REFRIGERATOR? IF YES, WAS IT ALLOWED TO REACH ROOM TEMPERATURE BEFORE USE? IT WAS IN THE FRIDGE BUT RETURNED TO ROOM TEMPERATURE BEFORE TRY TO ADMINISTER. PLEASE CAN YOU CONFIRM THE MAKE AND MODEL OF THE CONNECTING PRODUCTS? EQUASHIELD CLOSED SYSTEM SPIKE WAS ATTACHED TO BD SMARTSITE LOW SORBING SECONDARY SET. PLEASE CAN YOU CONFIRM IF THERE ARE ANY VISIBLE DEFECTS TO THE DEVICE I.E., CRACKS, FLASHES, KINKS? THERE DO NOT APPEAR TO BE ANY VISIBLE DEFECTS. PLEASE CAN YOU CONFIRM IF THE CONNECTING PRODUCT HAS A LUER SLIP OR LUER LOCK CONNECTION? LUER PLEASE CONFIRM WHETHER THE FLOW WA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25263187 ↗MalfunctionMay 22, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE LOW SORBING SECONDARY SET HAD KINKED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2026 CARFILZOMIB MADE FOR PT CORRECTLY. RN UNABLE TO BACK PRIME 2RY SET. TUBING APPEARS TO HAVE CRIMP IN IT WILL NOT ALLOW FLUID TO FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25263143 ↗MalfunctionMay 21, 2026Obstruction of Flow
IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PREPARED GEMCITABINE FOR PT PREPARED/CHK BY PHARM. THE IV ROOM PHARM DID FINAL INSPECTION ON THE PRODUCT PRIOR TO SENDING OUT FOR DELIVERY AND DISCOVERED THE 2DRY SET IS OCCLUDED BELOW THE DRIP CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249505 ↗MalfunctionMay 21, 2026Separation Failure
IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. PRIMARY TUBING FELL APART DURING PRIMING WITH IV FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248515 ↗MalfunctionMay 21, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RN PRIMED THE LINE W/ BD AP INFUSION SET. IMMEDIATELY NOTICED DRIPPING FROM THE AREA OF THE SAFETY CLAMP ON THE TUBING, PRIOR TO ATTEMPTING TO PLACE IN AP. CAN'T SEE A CRACK IN THE TUBING ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248510 ↗MalfunctionApr 27, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT RECEIVED A REPORT OF ONGOING PROBLEMS WITH BD SETS LEAKING, OUT OF THE PACKAGE SEPARATING OR NOT PRIMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25007995 ↗MalfunctionMar 26, 2026Complete Blockage
IT WAS REPORTED BY CUSTOMER THAT THEY HAD ANOTHER OCCLUSION ISSUE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706275 ↗MalfunctionMar 25, 2026Complete Blockage
IT IS REPORTED, BD SMARTSITE LOW SORBING SECONDARY SET BEING OCCLUDED. ADDITIONAL INFORMATION: PATIENTS HAD THEIR TREATMENT DELAYED AND SOMETIMES CANCELLED, CAUSING US TO WASTE THE PRODUCT THAT WAS PREPARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688243 ↗MalfunctionMar 25, 2026Complete Blockage
IT IS REPORTED, BD SMARTSITE LOW SORBING SECONDARY SET BEING OCCLUDED. ADDITIONAL INFORMATION: PATIENTS HAD THEIR TREATMENT DELAYED AND SOMETIMES CANCELLED CAUSING US TO WASTE THE PRODUCT THAT WAS PREPARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687829 ↗MalfunctionMar 25, 2026Complete Blockage
IT IS REPORTED, BD SMARTSITE LOW SORBING SECONDARY SET BEING OCCLUDED. ADDITIONAL INFORMATION: PATIENTS HAD THEIR TREATMENT DELAYED AND SOMETIMES CANCELLED CAUSING US TO WASTE THE PRODUCT THAT WAS PREPARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687344 ↗MalfunctionMar 25, 2026Complete Blockage
IT IS REPORTED, BD SMARTSITE LOW SORBING SECONDARY SET BEING OCCLUDED. ADDITIONAL INFORMATION: PATIENTS HAD THEIR TREATMENT DELAYED AND SOMETIMES CANCELLED CAUSING US TO WASTE THE PRODUCT THAT WAS PREPARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687341 ↗MalfunctionMar 25, 2026Complete Blockage
IT IS REPORTED, BD SMARTSITE LOW SORBING SECONDARY SET BEING OCCLUDED. ADDITIONAL INFORMATION: PATIENT'S HAD THEIR TREATMENT DELAYED AND SOMETIMES CANCELLED CAUSING US TO WASTE THE PRODUCT THAT WAS PREPARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687339 ↗MalfunctionMar 25, 2026Complete Blockage
IT IS REPORTED, BD SMARTSITE LOW SORBING SECONDARY SET BEING OCCLUDED. ADDITIONAL INFORMATION: PATIENTS HAD THEIR TREATMENT DELAYED AND SOMETIMES CANCELLED CAUSING US TO WASTE THE PRODUCT THAT WAS PREPARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687337 ↗MalfunctionMar 19, 2026Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641104 ↗MalfunctionJan 21, 2026Break
IT IS REPORTED BROKEN TUBE. VERBATIM: COMPLAINT CATEGORY: DAMAGED / BROKEN. DETAILS OF COMPLAINT (REPORTED ISSUE): THE SECONDARY TUBE WAS BROKEN AT CONNECTION POINT. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24138112 ↗MalfunctionJan 9, 2026Leak/Splash; Material Separation
LINES THAT DETACHED AFTER WE TRIED TO USE THIS LOT AGAIN THE LAST FEW DAYS. ADDITIONAL INFORMATION AS ON 22DEC2025: PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY FOR THE NUMBER OF LINES DETACHED ISSUE? DECEMBER 15, 16, 17. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM - CAUGHT IN PHARMACY BEFORE DISPENSING PRODUCT TO PATIENT CARE AREAS THIS TIME AS WE WERE AWARE OF THE POTENTIAL ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029056 ↗MalfunctionJan 9, 2026Leak/Splash; Material Separation
LINES THAT DETACHED AFTER WE TRIED TO USE THIS LOT AGAIN THE LAST FEW DAYS. ADDITIONAL INFORMATION AS ON 22DEC2025: PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY FOR THE NUMBER OF LINES DETACHED ISSUE? DECEMBER 15, 16, 17. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM - CAUGHT IN PHARMACY BEFORE DISPENSING PRODUCT TO PATIENT CARE AREAS THIS TIME AS WE WERE AWARE OF THE POTENTIAL ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029055 ↗MalfunctionJan 9, 2026Leak/Splash; Material Separation
LINES THAT DETACHED AFTER WE TRIED TO USE THIS LOT AGAIN THE LAST FEW DAYS. ADDITIONAL INFORMATION AS ON 22DEC2025: PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY FOR THE NUMBER OF LINES DETACHED ISSUE? DECEMBER 15, 16, 17 DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM - CAUGHT IN PHARMACY BEFORE DISPENSING PRODUCT TO PATIENT CARE AREAS THIS TIME AS WE WERE AWARE OF THE POTENTIAL ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24029051 ↗MalfunctionOct 21, 2025Disconnection; Disconnection
IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT SECONDARY TUBING SET FELL OUT OF A BAG OF RECLAST WHEN NURSE WAS HANGING MEDICATION ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350264 ↗MalfunctionOct 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT BREAKAGE/LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333681 ↗MalfunctionOct 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD SMARTSITE SECONDARY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT BREAKAGE/LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333680 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.