Alaris, VersaSafe 10796812Recalls & reported problems
BD Switzerland Sàrl · Gravity Set, Check Valve 3 Split septum ports, Vented/Nonvented 267 cm (105 in) · Class 2
All models of Alaris, VersaSafe (10)
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 10885403234316), received between Feb 17, 2020 and Feb 19, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Most reported problems
Device problems
- Fluid/Blood Leak4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. IT WAS OBSERVED THAT A DROP OF FLUID WAS ACCUMULATING AT THE INJECTION PORT. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, PATIENT INFORMATION NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9726248 ↗MalfunctionFeb 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, CUSTOMER UNABLE TO PROVIDE PATIENT INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9717602 ↗MalfunctionFeb 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM. ALTHOUGH REQUESTED, PATIENT INFORMATION NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9717566 ↗MalfunctionFeb 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A GRAVITY TUBING LEAK. THE EVENT OCCURRED ON A PET/CT UNIT, DURING AN ADMINISTRATION OF "F18 FLUORODEOXYGLUCOSE (RADIOACTIVE FLUORINE)," GIVEN WITH 21 GAUGE NEEDLE USING 3 ML SYRINGE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS AS A RESULT OF THIS EVENT. THE EVENT DID NOT CAUSE A SIGNIFICANT CHANGE IN COURSE OF TREATMENT FOR THE PATIENT, NOR REQUIRE MEDICAL OR SURGICAL INTERVENTION AS A RESULT. THERE WAS NO USER HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9717428 ↗
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 16, 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