Alaris 10794983Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10885403234293), received between Feb 26, 2020 and Sep 29, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934067 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933782 ↗
• MalfunctionSep 29, 2026Break

  It was reported that the BD Alaris Microbore Extension Set had damaged tubing. The following information was provided by the initial reporter: We are still experiencing tubing that is ¿breaking.¿ Our clinical staff in CW has most recently reported the following: 4 Bi Fuse: UMID 5371, MFG#: 10794983.Additional Information Received from the Customer: Was the fault observed before priming, during priming or after priming the set? Most are after priming and standard usePlease confirm the exact location of the reported fault within the set? At the Leur connection Did it fall apart at where the tubing connects? Yes.What was the impact to the patient? Loss of drug; risk of infection.Can you please provide an exact date of event in format dd-mmm-yyyy? Too many dates to provide. Risk reports were created.Can you please provide the Lot number associated with reported issue? I do not have specific Lot numbers as this has occurred over a several month period and the packaging has been thrown out as part of setting up the tubing.Can you please confirm all 4 Bi Fuse involve same patient or different patients? Different patients.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933776 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933775 ↗
• MalfunctionSep 24, 2026Leak/Splash

  It was reported that the BD Alaris Microbore Extension Set had leakage.The following information was provided by the initial reporter: Leaking extension set.Additional Information Received from the Customer:When was this defect observed? during or before use? During use.Can you please provide the Material number associated with reported issue? The material number was item number 10794983.Can you please provide the Lot number associated with reported issue? I do not have the Lot number.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889058 ↗
• MalfunctionMar 24, 2026Air/Gas in Device

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE AIR BUBBLES GOING IN ON ONE OF THE SIDES OF THE BIFUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675150 ↗
• MalfunctionMay 15, 2025Crack; Crack

  SAMPLE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030787 ↗
• MalfunctionFeb 11, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE IV SYRINGE TUBING BROKE WHEN RN DISCONNECTED SYRINGE WITH MINIMAL FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353519 ↗
• MalfunctionSep 24, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297534 ↗
• MalfunctionSep 17, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237948 ↗
• MalfunctionJan 10, 2024Difficult to Flush; Difficult to Flush

  NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490003 ↗
• MalfunctionDec 7, 2023Defective Component; Defective Component

  MATERIAL#: 10794983. BATCH NUMBER#: 22109371. CUSTOMER RESPONSE: WHAT IS THE DATE OF EVENT? 9/11/2023. SHARE THE BATCH NUMBER? LOT NUMBER AVAILABLE: 1022109371. PLEASE CONFIRM IF THE LEAKAGE WAS IDENTIFIED DURING PRIMING OR DURING INFUSION? IF DURING INFUSION, HOW LONG INTO THE INFUSION? N/A. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT. NO PATIENT HARM. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? DIRECTLY INVOLVED. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO PHOTO OR SAMPLE AVAILABLE. .PLEASE CONFIRM THE NUMBER OF OCCURRENCES. N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288880 ↗
• MalfunctionSep 21, 2023Failure to Prime; Failure to Prime

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: WHEN HANGING NEW IV FLUID AND LINES, I WAS UNABLE TO FLUSH THE BIFUSE FROM EITHER PORT. I REMOVED THE NADS AND STILL UNABLE TO FLUSH. PSR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795036 ↗
• MalfunctionApr 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS EXTENSION SET THERE WERE COMPONENTS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO WHITE CLIP ON ONE SECTION OF TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740435 ↗
• MalfunctionJul 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 Y MICROBORE EXT W/LUER & 2 SLD CLP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (IV) BIFUSER LEAKING IN PATIENT'S BED TWICE. CHANGED IV BIFUSER FIRST TIME WHEN THE BED AND IV TUBING WERE FOUND WET, FOUND IT TO BE LEAKING AGAIN ABOUT A HALF HOUR LATER. NO VISIBLE CRACKING NOTED. INFANT WAS NOT RECEIVING ORDERED FENTANYL DRIP AND VERSED DRIP BECAUSE THEY WERE LEAKING INTO BED. INFANT WAS EXTREMELY AGITATED AND THRASHING HEAD AROUND. INFANT IS INTUBATED AND WAS DANGEROUSLY AGITATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162677 ↗
• MalfunctionJun 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE Y MICROBORE EXT W/LUER & 2 SLD CLP EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10794983. BATCH/ LOT #: UNKNOWN (POSSIBLE 20095142) RN WAS RECONNECTING THE TUBING BACK TO THE PATIENT. WHEN RN LET GO, THE TUBING DISCONNECTED FROM THE PATIENT. LOOKING CLOSER (THERE WAS A BIFUSE AT THE END OF THE LINE) THE TWISTING PART OF THE BIFUSE WAS STILL CONNECTED TO THE PATIENTS PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) CAP AND THE REST OF THE LINE WAS NOT (THE TWISTING PART FELL OFF WHEN IT'S NOT SUPPOSED TO). FORTUNATELY, RN CAUGHT THE LINE BEFORE IT FELL ON THE FLOOR AND WAS ABLE TO SWAP OUT THE BIFUSE FOR A WORKING ONE. THERE WAS NO DETECTABLE HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996772 ↗
• MalfunctionMar 11, 2021Break; Connection Problem

  RECEIVED PATIENT AT START OF SHIFT WITH PAC INFUSING. 5 PORT IVF TUBING CONNECTED TO BIFURCATE EXTENSION, CONNECTED TO PHASAL, CONNECTED TO HEPARIN CAP AND PATIENT'S PAC. SHORTLY AFTER, BIFURCATE EXTENSION SET FOUND BROKEN WITH TUBING SNAPPED BELOW MALE CONNECTION. MALE CONNECTION REMAINED ATTACHED TO PHASAL. FEMALE CONNECTION INTACT WITH IVF TUBING.

  Patient problems: Insufficient Information

  MAUDE report 11462262 ↗
• MalfunctionMar 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE Y MICROBORE EXT W/LUER & 2 SLD CLP TUBING SNAPPED OFF BELOW THE MALE LUER CONNECTION TO THE PHASEAL SET. THIS OCCURRED ONCE EACH IN LOTS 20095142, 20095141, 20036894, AND AN UNSPECIFIED LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED PATIENT AT START OF SHIFT WITH PAC INFUSING. 5 PORT IVF TUBING CONNECTED TO BIFURCATE EXTENSION, CONNECTED TO PHASEAL, CONNECTED TO HEPARIN CAP AND PATIENT'S PAC. SHORTLY AFTER BIFURCATE EXTENSION SET FOUND BROKEN WITH TUBING SNAPPED BELOW MALE CONNECTION. MALE CONNECTION REMAINED ATTACHED TO PHASEAL. FEMALE CONNECTION INTACT WITH IVF TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458167 ↗
• InjuryFeb 24, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE Y  MICROBORE EXT W/LUER & 2 SLD CLP SETS DISTAL-END LUER LOCK COLLAR DISCONNECTED FROM THE SMALL BORE TUBING DURING USE. AS A RESULT, THE TUBING CONNECTIONS HAD TO BE CHANGED, LUMEN FLUSHED, EPI DRIP STARTED, AND "NOREPI, TACRO, AND MILRINONE" RESTARTED FOR THE PATIENT . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT IN CRITICAL CONDITION STARTED TO SHOW RAPID DETERIORATION, APPROPRIATE PROVIDERS AT BEDSIDE, MULTIPLE INTERVENTIONS BEING DONE TO STABILIZE PATIENT AND UPON GOING TO CONNECT EPI DRIP, IT WAS NOTED THAT THE BI-EXTENSION SET WHICH MULTIPLE INFUSIONS (NOREPI, TACRO, MILRINONE) WERE INFUSION HAD BROKE OFF FROM THE LUMEN. THE LUER LOCK PIECE WAS STILL ATTACHED HOWEVER THE PLASTIC PART WAS BROKE AND THEREFORE NOTED THAT THESE DRUGS WERE NOT INFUSING TO THE PATIENT. IT IS UNKNOWN EXACTLY HOW LONG THESE DRUGS WERE NOT INFUSING AS THE AREA DID NOT SEEM WET. TUBING CONNECTIONS CHANGES PROMPTLY, LUMEN FLUSHED WELL WITH NO ISSUES, DRUGS RE-STARTED AND EPI DRIP STARTED AS WELL." "LUER LOCK COLLAR AT DISTAL END BECAME DISCONNECTED FROM SMALL BORE TUBING".

  Patient problems: Insufficient Information; No Information

  MAUDE report 11369946 ↗
• MalfunctionNov 5, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT Y MICROBORE EXT W/LUER & 2 SLD CLP WAS CRACKED AND CAUSED UNDERINFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10794983; BATCH NO: 20036895. IT WAS REPORTED THAT BIFUSE CRACKED CAUSING SMOF LIPIDS TO NOT INFUSE FOR AN UNKNOWN AMOUNT OF TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10795447 ↗
• MalfunctionFeb 26, 2020Disconnection; Disconnection

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NURSE WENT TO HOOK PATIENT UP TO INTRAVENOUS TUBING, WHEN CONNECTING TUBING THE CAP OF TUBING FELL OFF LEAVING INTRAVENOUS TUBING ON PATIENT BEDSIDE WHILE CAP WAS CONNECTED TO PATIENT STILL." THERE WAS NO PATIENT IMPACT. AN INCOMPLETE DATE OF EVENT OF (B)(6) 2020 WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9756702 ↗