BD SmartSite 82113ERecalls & reported problems
BD Switzerland Sàrl · Add-on Burette Set, Needle-Free Valve (Burette) Vented/Nonvented 56 cm (22 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613203009591), received between Mar 13, 2019 and Jul 4, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash6
- Fluid/Blood Leak4
- Material Separation4
- Crack3
- Separation Problem2
- Break1
- Loose or Intermittent Connection1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 4, 2026Leak/Splash
IT WAS REPORTED THAT BD SMARTSITE BURETTE SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25710685 ↗MalfunctionJul 4, 2026Leak/Splash
IT WAS REPORTED THAT BD SMARTSITE BURETTE SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25710683 ↗MalfunctionMay 20, 2026Separation Problem
IT WAS REPORTED THAT BD SMARTSITE BURETTE SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE SECOND ONE THAT HAS FALLEN APART. ONCE IN THE MIDDLE OF A CASE, A SECOND ONE JUST FELL APART AT SET UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231365 ↗MalfunctionMay 20, 2026Separation Problem
IT WAS REPORTED THAT BD SMARTSITE BURETTE SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SECOND ONE THAT HAS FALLEN APART. ONCE IN THE MIDDLE OF A CASE, A SECOND ONE JUST FELL APART AT SET UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231357 ↗MalfunctionApr 15, 2026Break; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED, WHILE STARTING MAGNESIUM ON A PATIENT, THREE WERE LEAKING OR BROKE. ADDITIONAL INFORMATION: PLEASE CONFIRM THE NUMBER OF PATIENTS IMPACTED BY THIS ISSUE. 1. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? MAGNESIUM SULFATE. NO HARM TO THE PATIENT, BECAUSE THE BURETROLS BROKE DURING THE SET UP FOR INFUSION. IT DID CREATE AN INCREASED RISK TO THE PATIENT, BECAUSE THIS IS ONE OF OUR SAFEGUARDS TO PREVENT ACCIDENTAL OVERDOSE, SHOULD THE PUMP MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886556 ↗MalfunctionApr 9, 2026Leak/Splash; Separation Failure
IT WAS REPORTED, V/NV BURETTE SET, "CAME APART AND LEAKED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831064 ↗MalfunctionMar 23, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662053 ↗MalfunctionMar 23, 2026Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT BD GRAVITY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT BURETROL SETS LEAKING AT THE BOTTOM OF THE CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662042 ↗MalfunctionJan 28, 2026Material Separation
IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE FREE VALVE SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY A CUSTOMER THAT THE ENDS KEEP COMING OFF/POPPING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24203748 ↗MalfunctionJan 26, 2026Material Separation
END CAP IS COMING OFF THE BURETTE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24184192 ↗MalfunctionJan 26, 2026Material Separation
END CAP IS COMING OFF THE BURETTE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24183761 ↗MalfunctionNov 7, 2025Crack; Crack
IT WAS REPORTED THAT BD GRAVITY SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT REF 82113E WAS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497554 ↗MalfunctionSep 7, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE ADD-ON BURETTE SET SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SPIKE/CLOSURE PIERCING DEVICE, WHICH CONNECTS TO THE IV BAG, HAS BEEN DETACHING. ONE PACKET ARRIVED WITH THE SPIKE ALREADY SEPARATED FROM THE TUBING, AND OTHERS HAVE BECOME DISCONNECTED WHILE PITOCIN WAS INFUSING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE IMPACT TO THE PATIENT? ON (B)(6) 2025 PITOCIN BAG AND TUBINGS CHANGED IMMEDIATELY AFTER THE INCIDENT. INCIDENT INTERRUPTED CONTINUOUS ADMINISTRATION OF MEDICATION. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22989625 ↗MalfunctionAug 13, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD ALARIS SMARTSITE ADD-ON BURETTE SET HAD A LOOSE CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE-FREE VALVE (BURETTE) DEFECTED IN OUTPATIENT DIALYSIS PAR CART. THE SPIKE CONNECTOR WAS NOT SECURED PROPERLY. NOT SAFE FOR PATIENT TREATMENT. REMOVED AND REPLACED WITH NEW SETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797156 ↗MalfunctionOct 8, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT V/NV BURETTE SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 82113E BATCH NO: 18025628 IT WAS REPORTED THAT THE BODY OF THE BURETROL WAS SQUEEZED AND IT CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10652460 ↗MalfunctionApr 9, 2019Crack; Crack
IT WAS REPORTED THAT THE BURETTE CRACKED DURING AN IVIG INFUSION, NO MEDICATION WAS COMPRISED. NO PATIENT HARM. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8496065 ↗MalfunctionMar 13, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THEY SQUEEZED THE DRIP CHAMBER TO PULL IVIG INTO CHAMBER THE BURETTE CRACKED AND LEAKED A MINIMAL AMOUNT OF MEDICATION WHILE CONNECTED TO A PATIENT IN THE PNATL. THERE WAS NO HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8418248 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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