Alaris, VersaSafe 10796814Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403234330), received between Apr 20, 2022 and May 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS VERSASAFE EXTENSION SET EXPERIENCED DISCONNECTION AND LEAKED. THIS IS 2 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSTED BY USER, INTAKE ON 4/12/2023 12:48:21 AM INTAKE NOTE AFTER INSERTING A PIV AND FLUSHING THROUGH THE SLIP-TIP T-CONNECTOR, IT WAS ATTACHED AND SECURED WITH ADDITIONAL TAPE AT THE CONNECTION. APPROX 5 MINS LATER, BLOOD WAS NOTED ON THE ARMBOARD. UPON FURTHER ASSESSMENT, IT WAS DETERMINED THAT THE T-CONNECTOR HAD MIGRATED OUT SLIGHTLY AND BLOOD WAS BACKFLOWING OUT OF THE CATHETER. THE T-CONNECTOR WAS TIGHTENED AND FLUSHED, HOWEVER WHILE RETAPING, IT COULD BE SEEN FLOATING BACK OUT OF THE CATHETER. AT THIS TIME, THE NNP WAS AT BEDSIDE AND ASKED THIS RN TO UTILIZE OUR REGULAR SCREW ON TYPE OF T-CONNECTOR. THE T-CONNECTOR WAS CHANGED OUT AND THE PIV RETAPED WITH NO FURTHER ISSUES OF BLOOD LEAKING OUT. HAD I NOT BEEN AT BEDSIDE WHEN THIS HAPPENED, THE INFANT COULD HAVE LOST A LOT OF BLOOD DURING THE TIME THAT WOULD PASS BEFORE MY NEXT PIV CHECK 55 MINS LATER. IT IS A SAFETY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882186 ↗
• MalfunctionMay 5, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS VERSASAFE EXTENSION SET EXPERIENCED DISCONNECTION. THIS IS 1 OF 2 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSTED BY USER, INTAKE ON (B)(6) 2023 2:20:05 PM. INTAKE NOTE: RN OBTAINED PIV AND HAD STARTED A BLOOD TRANSFUSION. ORDERS RECEIVED TO RETAPE THE ETT, AS RT WAS POSITIONING PATIENT TO RETAPE, RT NOTICED THE "SLIP-TIP" HAD DETACHED FROM THE CATHETER HUB. ALSO, TO NOTE, PATIENT HAD RECEIVED A BOLUS OF AN ORDERED SEDATION MEDICATION AND IT HAD NOT TAKEN EFFECT YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882182 ↗
• MalfunctionApr 20, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS VERSASAFE EXTENSION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN NOTICED BLOOD BACKING UP IN THE TUBING AND THAT THE NEW KIND OF IV TUBING WE ARE USING BROKE. THE DISCONNECTION WAS NOT AT A SITE THAT NORMALLY COMES APART. IT WAS WHERE A NEEDLESS HUB AND THE TUBING MEET. THE TUBING SLIPPED APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164119 ↗