Alaris 10798703Recalls & reported problems
BD Switzerland Sàrl · Syringe Administration Set, Microbore Tubing segments, Check Valve, Anti-siphon Valve, Needle-Free Valve, Pressure Sensing Disk, Vented/Nonvented, 244 cm (96 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 10885403234378), received between Jan 23, 2019 and Feb 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
- Leak/Splash2
- Break1
- Crack1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Leak/Splash; Material Rupture
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401662 ↗MalfunctionOct 27, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT BD ALARIS SYRINGE SET WAS BROKEN: THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT PATIENT INFUSING TPN, CRACK DEVELOPED IN BAG TO SYRINGE LINE FOR LIPIDS AND WAS LEAKING, CREATING A WET CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389109 ↗MalfunctionJul 15, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT AN RN NOTICED THE TUBING SEVERED DURING THE TRANSPORTING OF A NICU PATIENT IN THE INCUBATOR. THE STAFF STATED; "THE LINE DID NOT COME IN CONTACT WITH ANY SHARP OBJECT". PER THE CUSTOMER, THERE WAS NO REPORTED HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8791405 ↗MalfunctionJan 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED TPN LEAKED FROM THE IV SET AT THE AREA OF THE PRESSURE SENSING DISK DURING AN INFUSION ON A NICU PATIENT. THE LEAK OCCURRED AN UNKNOWN NUMBER OF HOURS AFTER THE START OF THE INFUSION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8272861 ↗
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- 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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