Alaris, SmartSite 20041ERecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07613203011914), received between Dec 7, 2018 and Nov 10, 2025 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (16 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Leak/Splash; Nonstandard Device; Leak/Splash; Nonstandard Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE BLOOD STARTED COMING OUT OF BLUE PORT AND REMOVED EXTENSION TUBING, CONNECTED NEW TUBING WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23515177 ↗
• MalfunctionFeb 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE PLACEMENT OF ONE DAY, IT LEAKED FROM T-CON WHILE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351740 ↗
• MalfunctionSep 26, 2023Material Discolored; Material Discolored

  NO ADDITIONAL INFORMATION WAS PROVIDED. MAT#: 20041E. BATCH#: 22125048. IT WAS REPORTED BY THE CUSTOMER THAT "(B)(6) RECENTLY RECEIVED A BATCH OF T-CONNECTORS THAT ARE DISCOLORED YELLOW. STAFF HAVE PULLED MULTIPLE T-CONNECTORS THAT LOOK LIKE THIS AND THEY ARE FROM THE SAME LOT. HOWEVER THERE ARE SOME FROM THIS LOT THAT ARE NOT YELLOWED AND JUST CLEAR". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(6) RECENTLY RECEIVED A BATCH OF T-CONNECTORS THAT ARE DISCOLORED YELLOW. STAFF HAVE PULLED MULTIPLE T-CONNECTORS THAT LOOK LIKE THIS AND THEY ARE FROM THE SAME LOT. HOWEVER THERE ARE SOME FROM THIS LOT THAT ARE NOT YELLOWED AND JUST CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821409 ↗
• MalfunctionSep 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  NEW INFO: FINAL MATERIAL NUMBER IS 22602-B007T, THIS IS WHAT THE SAMPLE WAS THAT WAS RETURNED. THERE IS NO GOOD BATCH NUMBER REPORTED FOR THIS MATERIAL. LOT NUMBER UNKNOWN MOST RECENT FOLLOW-UP WITH CUSTOMER CONFIRMS THIS MATERIAL #. MATERIAL #: 20041E, BATCH #: 22125048. IT WAS REPORTED BY CUSTOMER THAT NEW TUBING'S PRIMED WITH TACROLIMUS. AFTER CONNECTING TO THE PATIENT AND STARTED THE MEDICATIONS, NOTED LEAKING FROM THE SENSOR TUBING'S. LEAK HAPPENED ABOUT 1 HOUR AFTER THE TACRO BAG WAS CHANGED. RN (D.V.) HAD TO RESPIKE WITH THE BAG WITH A NEW TUBING, AS THERE WAS NO SPARE TACRO BAG ON THE FLOOR. VERBATIM: GOOD AFTERNOON. ON (B)(6) 2023, WE HAD A SAFETY EVENT REPORTED FOR BD ITEM # 22602-B007T (BD ALARIS PUMP INFUSION SET). LET¿S IDENTIFY THIS AS BD 245, AS A REFERENCE NUMBER. THE DEFECTIVE PRODUCT IS AVAILABLE FOR PICK UP FROM DEFECT DEPOT. PLEASE CONTACT XXX (COPIED HERE) WITH ANY QUESTIONS YOU MAY HAVE ABOUT PICK UP. BASED ON THE INFORMATION PROVIDED BELOW, COULD YOU START A PRODUCT QUALITY REPORT? BD 245: REPORTED DATE: (B)(6) 2023; EVENT DATE: 08/26/2023; ITEM NUMBER: 22602-B007T; LOT NUMBER: 22126284; ITEM RETAINED IN DEFECT DEPOT?: YES; PICTURE: NO; PATIENT HARM: NO HARM;

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795369 ↗
• MalfunctionJul 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 4 OF THE BD SMARTSITE¿ EXTENSION SET, PRESSURE RATED SMARTSITE¿ T-CONNECTOR LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE EXTENSION TUBE LEAKS WHEN THE DRUG IS INJECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17338354 ↗
• MalfunctionNov 9, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET TUBING WAS CUT WHILE PACKAGING IT UP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE TUBE OF THE CONNECTOR WAS CUT DURING THE PROCESS OF PACKAGING UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764778 ↗
• MalfunctionAug 29, 2022Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD SMARTSITE¿ EXTENSION SET, PRESSURE RATED SMARTSITE¿ T-CONNECTOR THE TUBING CONNECTION WAS LOOSE AND LEAKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT IT "LEAKS AND WILL NOT ATTACH ALL THE WAY TO THE IV TUBING". VERBATIM: LEAKS AND WILL NOT ATTACH ALL THE WAY TO THE IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317335 ↗
• MalfunctionApr 15, 2022Separation Failure; Separation Failure

  IT WAS REPORTED THAT 10 BD SMARTSITE¿ EXTENSION SETS WERE DIFFICULT TO DISCONNECT FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAN NOT BE SEPARATED FROM THE SCREW CONNECTOR OF THE INTRAVENOUS INFUSION SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121802 ↗
• MalfunctionApr 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 3 BD ALARIS SMARTSITE EXTENSION SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTRAST MEDICATION LEAKED AFTER CONNECTING WITH THE OPEN END FOR POWER INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017439 ↗
• MalfunctionDec 20, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED WHEN USING THE BD SMARTSITE¿ EXTENSION SETS, THE DEVICE EXPERIENCED AN OCCLUSION. THIS EVENT OCCURRED TWO TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CONNECTOR OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048337 ↗
• MalfunctionDec 20, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED WHEN USING THE BD SMARTSITE¿ EXTENSION SETS THE DEVICE WAS CLOGGED, BLOCKED, OR OCCLUDED. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE CONNECTOR COULDN¿T BE FLUSH DURING IV INFUSION AND PRIMING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044547 ↗
• MalfunctionDec 16, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED WHEN USING THE BD T-CONN W/LL & 1 VLV PORT, THE DEVICE EXPERIENCED AN OCCLUDED PRODUCT. THIS EVENT OCCURRED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE BODY OF SMARTSITE OCCLUSION DURING POWER INJECTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13021781 ↗
• MalfunctionNov 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD (B)(6) EXTENSION SET EXPERIENCED DAMAGED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM (B)(6) TO ENGLISH: TUBE WAS BROKEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866146 ↗
• MalfunctionNov 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD SMARTSITE¿ EXTENSION SETS THE TUBING WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TUBE WAS BROKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781239 ↗
• MalfunctionOct 15, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED T-CONN W/LL & 1 VLV PORT HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN TIGHTENING THE CONNECTION, THE PIECE THAT TURNS CONTINUES TO TURN PAST THE POINT OF TIGHTENING. SAME THING HAPPENING WITH THREE DIFFERENT LOT NUMBERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12637900 ↗
• MalfunctionOct 7, 2021Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED T-CONN W/LL & 1 VLV PORT WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE HUB CONNECTED WITH SYRINGE BROKEN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594991 ↗
• MalfunctionSep 22, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 8 T-CONN W/LL & 1 VLV PORT EXPERIENCED FLOW ISSUES, AND WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VALVE MALFUNCTION, UNABLE TO INJECT OR HAVE RESISTANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512181 ↗
• MalfunctionSep 20, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET PACKAGING UNIT SEAL WAS DAMAGED/COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE USER FOUND BROKEN TUBE IN THE PACKAGE" VIA BD INVESTIGATION: "A CLOSER INSPECTION NOTED THAT THE SEAL OF THE PACKAGING HAD BEEN COMPROMISED, SUGGESTING THAT THE TUBING HAD PROTRUDED OUT OF THE PACKAGING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12499221 ↗
• MalfunctionAug 12, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 5 T-CONN W/LL & 1 VLV PORT VALVES WERE BLOCKED/OCCLUDED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VALVE MALFUNCTION, UNABLE TO INJECT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316568 ↗
• MalfunctionAug 4, 2021Complete Blockage; Restricted Flow rate; Free or Unrestricted Flow; Complete Blockage; Restricted Flow rate; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE T-CONN W/LL & 1 VLV PORT EXPERIENCED FLOW ISSUES, CHECK VALVE MALFUNCTION, AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VALVE MALFUNCTION, UNABLE TO INJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278332 ↗
• MalfunctionAug 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED T-CONN W/LL & 1 VLV PORT LEAKED WHEN USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLOOMINGTON NICU REPORTS A LEAKY CONNECTION BETWEEN THE BD EXTENSION SET SMALLBORE TUBING AND THE SMARTSITE EXTENSION SET. BLOOMINGTON NICU REPORTS A LEAKY CONNECTION BETWEEN THE BD EXTENSION SET SMALLBORE TUBING AND THE SMARTSITE EXTENSION SET. THEY DID NOT SAVE THE PACKAGING AND CANNOT PROVIDE LOT NUMBERS, BUT I DO HAVE THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264387 ↗
• MalfunctionAug 2, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT 2 T-CONN W/LL & 1 VLV PORT SETS HAD OCCLUDED FLOW DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLOW OCCLUSION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264330 ↗
• MalfunctionJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT T-CONN W/LL & 1 VLV PORT WAS DAMAGED AND LEAKED BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE VALVE WAS DEFECTIVE AND LEAKED BLOOD OUT OF CAP AFTER IT WAS CONNECTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202438 ↗
• MalfunctionJun 8, 2021Backflow; Leak/Splash; Backflow; Leak/Splash

  IT WAS REPORTED THAT A T-CONN W/LL & 1 VLV PORT EXPERIENCED BLOOD BACKFLOW AND RUPTURED TUBING DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I RECEIVED THIS PRODUCT THIS MORNING WITH THE ATTACHED NOTE. PRODUCT IS AVAILABLE AND LOT # IS (10) 20126459 MOM REPORTED IV TUBING WAS LEAKING. RN ASSESSED AND FOUND BLOOD BACKING UP IN THE BD SMARTSITE EXTENSION SET (REF20041E). FLUID LEAKING FROM A HOLE IN THE TUBING BETWEEN THE THIN TUBING PORTION AND THE "HUB" OF THE CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963530 ↗
• MalfunctionMay 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE T-CONN W/LL & 1 VLV PORT TUBING WAS DEFECTIVE AND SEPARATED IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE USER FOUND BROKEN TUBE IN THE PACKAGE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838907 ↗