Alaris 30914Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10885403233319), received between Aug 16, 2018 and Mar 2, 2023 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE WITH BD ALARIS¿ EXTENSION SET THE TUBING WAS DISCOVERED TO BE SEALED TOGETHER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PART OF THE TUBING IS SEALED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465266 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET LUER-LOK CAP BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I JUST RECEIVED ANOTHER SAMPLE WITH THE LUER CAP BROKEN AWAY FROM THE END."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134806 ↗
• MalfunctionDec 20, 2022Loose or Intermittent Connection; Air/Gas in Device; Loose or Intermittent Connection; Air/Gas in Device

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET HAD A LOOSE CONNECTION AND ALLOWED AIR TO ENTER THE LINE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LUER LOCK END OF EXTENSION TUBING DEFECTIVE. WOULD NOT TIGHTEN TO FORM A CLOSED SYSTEM. ALLOWED AIR TO ENTER LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016685 ↗
• MalfunctionDec 12, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET EXPERIENCED A LOOSE IV SET CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE LUER-LOK CONNECTION THAT DOESN¿T CREATE A SECURE CONNECTION AND ALLOWS AIR TO ENTER THE LINE. WE HAVE HAD TO SWITCH TO USING ALL MICROBORE WITH THE PRESSURE-SENSING DISC UNTIL WE CAN TRY A NEW LOT #.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964034 ↗
• MalfunctionDec 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ EXTENSION SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSSIBLE LEAKAGE BETWEEN THE VALVE AND TUBING. I AM NOT SURE IF ITS BECAUSE WE ARE USING TWO DIFFERENT PRODUCTS. THE VALVE IS AN ICU PRODUCT CONNECTED TO THE BD TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941847 ↗
• MalfunctionNov 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET EXPERIENCED LEAKAGE.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756957 ↗
• MalfunctionAug 5, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBORE EXTENSION WOULD NOT FLUSH - HOLE DOESN'T GO THROUGH THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179980 ↗
• MalfunctionAug 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING WAS BROKEN WHEN TAKEN OUT OF THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176182 ↗
• MalfunctionAug 4, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD IV EXTENSION SET EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH ANY FLUID THROUGH TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170783 ↗
• MalfunctionAug 4, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 2 BD IV EXTENSION SETS WOULD NOT PRIME OR FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON BOTH OCCASIONS WOULD NOT FLUSH/PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164752 ↗
• MalfunctionAug 1, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET WOULD NOT FLUSH FLUID THROUGH THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH ANY FLUID THROUGH TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140794 ↗
• MalfunctionJul 29, 2022Break; Break

  IT WAS REPORTED THAT THE BD EXTENSION SET MICROBORE EXPERIENCED DAMAGE PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN AT UTILIZATION. ONE OF THE CONNECTOR TIPS / AREA FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136384 ↗
• MalfunctionJul 29, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD EXTENSION SET MICROBORE EXPERIENCED CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNABLE TO FLUSH ANY FLUID THROUGH TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136098 ↗
• MalfunctionJul 22, 2022Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED THAT MOLD WAS PRESENT WITHIN THE BD ALARIS¿ EXTENSION SET CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLACK MOLD OR MILDEW IN CAP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089469 ↗
• MalfunctionJul 15, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING EXTENSION SET MIC TUBING 60 INCH THAT THERE WAS A CRACK IN THE TUBING AND LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MICROBORE EXTENSION SET USED HAD PRIMED WITH EASE. PLACED THE HIZENTRA MEDICATION SYRINGE INTO THE IV ALARIS PUMP. AFTER STARTING THE MEDICATION TO INFUSE, NOTICED IMMEDIATELY LEAKAGE FROM THE MEDICATION SYRINGE TIP AND MICROBORE EXTENSION SET. REMOVED MEDICATION FROM THE IV ALARIS PUMP AND ASKED ANOTHER COLLEAGUE TO HELP ME ASSESS THE SYRINGE AND TUBING. WE REMOVED THE HIZENTRA MEDICATION SYRINGE AND ASSESSED FOR ANY CRACKS IN THE TIP OF THE SYRINGE. WE THEN ASSESSED THE TUBING AND PLACED A 5 ML NS SYRINGE ONTO THE TIP OF THE MICROBORE EXTENSION SET AND IMMEDIATELY SAW A LEAK ON THE SIDE OF THE INSERTION SITE TIP OF THE TUBING. THERE IS A CRACK IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15034091 ↗
• MalfunctionJun 10, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MICROBORE TUBING EXTENSION SETS EXPERIENCED BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING IS NOT PATENT AND FLUID DOES NOT PASS THROUGH THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651823 ↗
• MalfunctionApr 27, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD SOME OCCLUSION IN SOME OF OUR MICROBORE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14226864 ↗
• MalfunctionApr 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET LEAKED FROM THE TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN HUNG MEDICATION, RETURNED TO CHECK IF IT WAS FINISHED AND NOTICED THE TUBING WAS WET, FLOOR HAD PUDDLE AND IT SEEMED LIKE THE TUBING ITSELF WAS LEAKING. MINOR EFFECT TO PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162127 ↗
• MalfunctionApr 20, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD EXTENSION SET MICROBORE SLIDE CLAMP 0.55 ML FLUID PATH STERILE THE TUBING WAS BLOCKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE LINE UNABLE TO FLUSH ANY FLUIDS OR MEDS. NO VISIBLE DAMAGE TO LINE. NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160222 ↗
• MalfunctionApr 19, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED BD ALARIS¿ EXTENSION SET HAD BLOCKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING DOES NOT ALLOW PUSHING OF FLUIDS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14145544 ↗
• MalfunctionApr 18, 2022Complete Blockage; Failure to Prime; Complete Blockage; Failure to Prime

  IT WAS REPORTED THAT 5 BD ALARIS EXTENSION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING WAS FOUND TO BE DEFECTIVE WHILE PREPPING THE TUBING. I HAVE 5 SETS THAT WILL NOT PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136892 ↗
• MalfunctionApr 1, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET TUBING WAS BLOCKED AND MEDICATION COULDN'T BE FLUSHED THROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO FLUSH MEDICATION THROUGH SYRINGE TUBING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977154 ↗
• MalfunctionMar 14, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AT LEAST 2 BD ALARIS EXTENSION SETS WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL HAS EXPERIENCED MULTIPLE INCIDENTS INVOLVING BD 60-INCH MICROBORE TUBING THAT WOULD NOT PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759606 ↗
• MalfunctionFeb 10, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING BLOCKED. COMPLAINT NOTICED: PRIOR TO USE. PATIENT INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510077 ↗
• MalfunctionFeb 8, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 9 TOTAL BD ALARIS¿ EXTENSION SETS FROM VARIOUS, UNSPECIFIED LOTS HAD FLOW AND BLOCKAGE ISSUES WHERE THEY COULDN'T BE PRIMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE CONTINUING TO HAVE ISSUES WITH THIS TUBING WITH DIFFERENT LOT NUMBERS. WE HAVE HAD THREE MORE INCIDENTS THAT HAVE HAD TUBING THAT IS UNABLE TO PRIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480959 ↗