Alaris, SmartSite 20519ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403234941), received between Sep 2, 2020 and Feb 23, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE SET THAT WAS NOT STAYING CONNECTED AND THE ONE THAT WAS CRACKING WHEN ADDED THE MAXZERO CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442790 ↗
• MalfunctionFeb 23, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE SET THAT WAS NOT STAYING CONNECTED AND THE ONE THAT WAS CRACKING WHEN ADDED THE MAXZERO CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442775 ↗
• MalfunctionFeb 9, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 20519E BATCH NUMBER#: 23089095 IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING ISSUES WITH MANIFOLD EXTENSION AGAIN. IT IS COMING UNDONE AT THE CONNECTION THAT I HAVE CIRCLED. THAT CONNECTION IS TOGETHER WHEN OPENING THE PACKAGE BUT IF DO NOT TIGHTEN IT, SOME WILL COME APART AND EITHER LEAK OR FALL OFF ONTO THE FLOOR OR DESK, THEN WE HAVE TO GET ALL NEW TUBING. THIS INSTANCE HAPPENED TODAY AND ANOTHER INCIDENCE ABOUT 1 MO. AGO. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE SEE THE FOLLOWING COMPLAINT RECEIVED FROM (B)(6) . MATERIAL AND LOT NUMBER IS UNKNOWN BUT IS MOST LIKELY MP5312-C OR (INFUSION DISPOSABLE) WE HAVE BEEN HAVING ISSUES WITH OUR MANIFOLD EXTENSION AGAIN. IT IS COMING UNDONE AT THE CONNECTION THAT I HAVE CIRCLED. THAT CONNECTION IS TOGETHER WHEN WE OPEN THE PACKAGE BUT IF WE DO NOT TIGHTEN IT, SOME WILL COME APART AND EITHER LEAK OR FALL OFF ONTO THE FLOOR OR DESK, THEN WE HAVE TO GET ALL NEW TUBING. THIS INSTANCE HAPPENED TODAY AND ANOTHER INCIDENCE ABOUT 1 MO. AGO. PLEASE OPEN A NEW COMPLAINT FOR THIS AND CONFIRM THE MATERIAL NUMBER WITH (B)(6) . CUSTOMER REPLY: DATE WAS DAY OF EMAIL ONLY MATERIAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675788 ↗
• MalfunctionApr 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT UNSPECIFIC NUMBER OF BD ALARIS¿ SMARTSITE¿ EXTENSION SET EXPERIENCED LEAKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS ANOTHER INSTANCE IN ENDO THAT THE MANIFOLD CONNECTION CAME LOOSE AND WAS LEAKING BUT DID NOT COME COMPLETELY APART. THERE WERE SEVERAL INSTANCES THAT THE EXTENSION TO THE ANGIOCATH WOULD BE LEAKING, AND THE NURSES HAD TO CHANGE THE DRESSING AND TIGHTEN THE CONNECTION. THERE WAS NO ADVERSE EVENT. IT JUST DELAYED THE PATIENT GETTING TO SLEEP FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770442 ↗
• MalfunctionApr 19, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET CAME APART DURING USE AND LEAKED MEDICATION DOWN THE PATIENT'S BACK. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MANIFOLDS HAVE BEEN COMING APART AND LEAKING, AND THE CONNECTION WITH THE EXTENSION TO THE ANGIO SEEMS TO NOT SCREW ON VERY TIGHT AND LEAKS AT THAT SPOT. BD SMARTSITE EXT SET 3 PORT MANIFOLD - # 20519E COMING APART WHERE CIRCLED AND AIR LOCKING. DETAILS: PT. WAS IN ENDO BEING PUT TO SLEEP AND THE ANESTHESIA PROVIDER STATED THAT THE CONNECTION OF ITEM 7592897 TO THE ANGIO WAS LEAKING. HE TIGHTENED THAT CONNECTION THEN WENT TO THE MANIFOLD ((B)(6)), STARTED GIVING PROPOFOL AND THE CONNECTION THERE CAME APART COMPLETELY AND SPRAYED THE PATIENT DOWN HER BACK. THERE WAS NO ADVERSE EVENT. IT JUST DELAYED THE PATIENT GETTING TO SLEEP FOR THE PROCEDURE. PROCEDURE: EGD AND COLONOSCOPY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770314 ↗
• MalfunctionJun 18, 2021Leak/Splash; Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult or Delayed Separation; Leak/Splash; Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult or Delayed Separation

  IT WAS REPORTED THAT 3-PORT MANIFOLD W/EXT SET WAS DIFFICULT TO DISCONNECT LINES AND HAD A CRACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE ITEM IS DIFFICULT TO CREW AND UNSCREW LINES FROM AND SOMETIMES CRACK. VERBATIM: THE ICU STAFF HAS HAD SOME CONCERNS AND COMPLAINTS ABOUT OUR CURRENT IV MANIFOLDS THAT WE HAVE. THEY HAVE INFORMED ME THAT THEY ARE DIFFICULT TO SCREW AND UNSCREW LINES FROM AND SOMETIMES CRACK. I WOULD LIKE TO CHANGE THE PRODUCT WE ARE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028502 ↗
• MalfunctionSep 2, 2020Complete Blockage; Free or Unrestricted Flow; Complete Blockage; Free or Unrestricted Flow

  IT WAS REPORTED THAT 3-PORT MANIFOLD W/EXT SET MALFUNCTIONED ON 139 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20519E BATCH(LOT) NO: 20016722. IT WAS REPORTED FROM ANESTHESIA THAT SEVERAL EXTENSION TUBING SETS WERE FOUND TO HAVE THE DISTAL PORT FACING THE WRONG DIRECTION. THERE WAS NO PATIENT INVOLVEMENT. IT WAS BROUGHT TO MY ATTENTION TODAY THAT THE SAME LOT # FOR THE BD SMARTSITE EXTENSION SET WITH THE 3 PORT MANIFOLD THAT IS USED FOR ANESTHESIA MEDICATIONS HAS A DEFECT WITH SOME OF THE SUPPLY. THE DISTAL PORT IS FACING THE WRONG DIRECTION WHICH MAKES THE MEDICATION GO UP THE LINE INSTEAD OF DOWN AND INTO THE PATIENT¿S SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10486374 ↗