Alaris 10014918Recalls & reported problems
BD Switzerland Sàrl · Syringe Low Sorbing Administration Set, Macro Bore Tubing, Pressure Sensing Disc 152 cm (60 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403233944), received between Dec 14, 2021 and Mar 25, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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/Splash2
- Complete Blockage1
- Material Puncture/Hole1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18969537 ↗MalfunctionFeb 2, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: READING "OCCLUDED" EVEN WHEN DETACHED FROM THE PATIENT. MED LINE TUBING WAS DISCONNECTED FROM THE PATIENT AND STILL READ "OCCLUDED" ON THE ALARIS PUMP. BECAUSE OF THIS, ABOUT 0.2ML OF MEDICATION WAS UNABLE TO BE GIVEN TO PATIENT. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18635363 ↗MalfunctionJan 29, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18596232 ↗MalfunctionDec 14, 2021Material Separation; Material Separation
IT WAS REPORTED WHEN USING THE BD ALARIS SYRINGE MODULE SYRINGE ADMIN. SET THE DEVICE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WHEN I WENT TO RE-TRACE THE LINE I NOTICED THE PRESSURE DISK WAS IN THE SENSOR BUT THE TUBING WAS DISCONNECTED FROM THE DISK RIGHT BELOW THE DISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13006210 ↗
Other Set, administration, intravascular devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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