Alaris 82113Recalls & reported problems
BD Switzerland Sàrl · Add on Burette Set, Injection Port (Burette) Vented/Nonvented 56 cm (22 in) · Class 2
All models of Alaris (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613203009614), received between Jun 21, 2022 and Oct 11, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash3
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2022Break; Break
IT WAS REPORTED THAT THE SPIKE TIP BROKE OFF WHEN INSERTED INTO THE BD ALARIS¿ ADD-ON BURETTE SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TIP OF SPIKE BROKE OFF DURING INSERTION INTO BURETTE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15576085 ↗MalfunctionSep 15, 2022Material Separation; Material Separation
IT WAS REPORTED THAT THE BD ALARIS¿ ADD-ON BURETTE SET CAME APART WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOMETHING ABOUT THE END CAPS ARE LOOSE. CLINICAL REPORTED "IT DIS-ASSEMBLED ITSELF WHEN TAKING IT OUT OF THE PACKAGE"".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15433575 ↗MalfunctionJun 27, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS ADD-ON BURETTE SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD SEVERAL MORE LEAKING BUTESTROL DISCOVERED OVER THE WEEKEND WITH THIS SAME LOT #. ONE NURSE NOTED THAT THERE APPEARS TO BE AN ISSUE WITH THE ADHESIVE ON THE BOTTOM OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14836046 ↗MalfunctionJun 27, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 4 BD ALARIS ADD-ON BURETTE SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD SEVERAL MORE LEAKING BUTESTROL DISCOVERED OVER THE WEEKEND WITH THIS SAME LOT #. ONE NURSE NOTED THAT THERE APPEARS TO BE AN ISSUE WITH THE ADHESIVE ON THE BOTTOM OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14835927 ↗MalfunctionJun 21, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS ADD-ON BURETTE SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADD-ON BURETTE SET FOR IV MEASUREMENT APPEAR TO BE LEAKING FROM THE BASE OF THE SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14754176 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page