Alaris, SmartSite 30262ERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613203011471), received between Jul 11, 2019 and Aug 30, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WITH THE VERBATIM: TUBING IS DISCOLORED, NURSING DISCOVERED WHEN GRABBING FOR PATIENT TUBING. DID NOT REACH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654750 ↗
• MalfunctionMay 10, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THE TUBING WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CURRENT EXTENSION TUBING IS STILL STIFFER THAN THE IV TUBING. WE BEND THE EXTENSION TUBING TO TAPE IT, AND THIS STIFFNESS CAUSES TENSION ON THE SITE OF INSERTION, LEADING TO DIFFICULTY TAPING THE IV IN PLACE AND INCREASED INADVERTENT DISLODGEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903477 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT 2 BD ALARIS¿ SMARTSITE¿ EXTENSION SETS' TUBING BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING BROKE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118210 ↗
• MalfunctionOct 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKED BLOOD FROM THE TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RN PLACED EXTENSION TUBING ON IV LINE, PROPERLY PRIMED AND RECONNECTED TO PATIENT. APPROXIMATELY 10 MINUTES LATER THE PATIENT CALLED RN BACK TO ROOM. THE ENTIRE EXTENSION TUBE WAS FULL OF BLOOD AND WAS LEAKING NEAR THE CONNECTION TO THE IV TUBING. AFTER ATTEMPTING TO FLUSH THE LINE IT WAS DISCOVERED THAT THE EXTENSION LINE WAS LEAKING FROM THE TUBING NOT A POOR CONNECTION. RN REPLACED THE EXTENSION TUBING WITH NEW AND RESTARTED THE IV."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660195 ↗
• MalfunctionNov 6, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BD ALARIS SMARTSITE EXTENSION SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 30262E-P1, BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THE PRODUCT IN PACKAGING DID NOT MATCH THE SKU#. VERBATIM: PRODUCT IN PACKAGING DID NOT MATCH THE SKU#.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755811 ↗
• MalfunctionSep 30, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET MALE LUER WAS DAMAGED AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MALE LUER BENT." "DID YOU EXPERIENCE ANY ADVERSE EVENTS? NO, JUST LEAKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555454 ↗
• MalfunctionSep 30, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 2 BD ALARIS SMARTSITE EXTENSION SETS' MALE LUERS WERE DAMAGED AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MALE LUER BENT" "DID YOU EXPERIENCE ANY ADVERSE EVENTS? NO, JUST LEAKING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555366 ↗
• MalfunctionSep 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE 40 INCH EXT W/2 VLV PORTS THERE WAS COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE CONNECTION CAME OFF EXTENSION SET. THERE WAS NO CLAMP SLIDE ON THE ALARIS SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470768 ↗
• MalfunctionJul 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 40 INCH EXT W/2 VLV PORTS LUER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MALE LUER BENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208036 ↗
• MalfunctionOct 12, 2020Difficult to Remove; Difficult or Delayed Separation; Difficult to Remove; Difficult or Delayed Separation

  IT WAS REPORTED THAT 40 INCH EXT W/2 VLV PORTS WAS DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: MZ9267 BATCH NO.: 20056291 IT WAS REPORTED THE MAXZERO IS DIFFICULT TO DISCONNECT; IT WAS FUSED INTO THE SMARTSITE OF THE ALARIS EXTENSTION SET 30262E AFTER CLEANING WITH CHG/ALCOHOL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10665647 ↗
• MalfunctionJul 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 40 INCH EXT W/2 VLV PORTS WAS CRACKED AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 30262E BATCH NO: 20046788. IT WAS REPORTED THE EXTENSION TUBING CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10274132 ↗
• MalfunctionJan 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING WAS LEAKING AT THE CONNECTION. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Information

  MAUDE report 9608477 ↗
• MalfunctionJul 11, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE EXTENSION TUBING CONNECTED TO A NONBD TRI-FUSE TUBING DISCONNECTED FROM THE PART THAT CONNECTS ON THE PT LINE (ROTATING LUER). THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8782265 ↗