Alaris, SmartSite 37262ERecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10885403235276), received between Jul 27, 2018 and Mar 16, 2026 — classified as 2 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608074 ↗
• MalfunctionJan 15, 2026Air/Gas in Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086248 ↗
• MalfunctionJan 13, 2026Air/Gas in Device

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET HAD AIR IN LINE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT BD INFUSION SETS ARE PULLING AIR IN AT THE PORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058141 ↗
• MalfunctionJan 6, 2026Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING IT WAS REPORTED BY CUSTOMER THAT THEY HAD A FEW EXTENSION SETS #37262E LEAK OUT THROUGH THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977188 ↗
• MalfunctionOct 27, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY TOOK ANOTHER CALL FROM THE PROCEDURE CENTER AS IT HAPPENED AGAIN THIS MORNING. SHE ALSO NOTED THAT ANOTHER TUBING SET WAS WITHOUT A CLAMP - WHERE IT ALWAYS HAS A CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397031 ↗
• MalfunctionOct 27, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THERE WAS NO ACTION HAPPENING DURING THE BREAK. IT HAD BEEN ATTACHED TO THE PRIMARY TUBING AND TO THE PATIENT. THE TUBING PULLED APART AT THE SITE IN THE PICTURE 4833 IN THE BOTTOM LEFT OF THE IMAGE AND THEN BLOOD CAME BACK INTO THE TUBING (SO THEY COULDN'T SAVE THAT PIECE TO GIVE TO ME - 4834 IS A NEW PRODUCT WITH THE IMAGE OF WHAT GOT DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389110 ↗
• MalfunctionOct 27, 2025Separation Failure; Separation Failure

  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 THERE WAS NO ACTION HAPPENING DURING THE BREAK. IT HAD BEEN ATTACHED TO THE PRIMARY TUBING AND TO THE PATIENT. THE TUBING PULLED APART AT THE SITE IN THE PICTURE 4833 IN THE BOTTOM LEFT OF THE IMAGE AND THEN BLOOD CAME BACK INTO THE TUBING (SO THEY COULDN'T SAVE THAT PIECE TO GIVE TO ME - 4834 IS A NEW PRODUCT WITH THE IMAGE OF WHAT GOT DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389108 ↗
• MalfunctionOct 19, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE CONNECTOR OF THE EXTENSION SET IS LOOSE AND THAT IT LEAKS.

  Patient problems: Insufficient Information

  MAUDE report 23333607 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  EVENT DETAILS: FALLING APART AT THE PIG TALES, IT LOOKS LIKE ITS NOT GLUED IN RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301291 ↗
• MalfunctionAug 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET HAD SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING SET COMPLETELY DETACHED FROM SMARTSITE Y-SITE. JUST BELOW WHILE CARRIER FLUID WAS BEING ADMINISTERED. PATIENT AND HCP WERE NOT HARMED OR EFFECTED DURING THIS EVENT AS THIS WAS NOT A HAZARDOUS DRUG. IT CONTAINED CARRIER FLUID THAT BOTH THE PATIENT AND HCP WERE EXPOSED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: AT WHAT POINT DID THIS FAILURE OCCUR? DURING PATIENT CARE. ONE TIME FOR ME IN PACU. ONE TIME FOR BRADD SWEATT DURING A CASE. WHAT WAS THE MEDICATION TYPE AND DURATION OF THE INFUSION? MEDICATION: I DO NOT RECALL. DID THE PATIENT RECEIVE A COMBINATION OF ANY MEDICATIONS? I DO NOT RECALL. HOW LONG HAS THIS PRODUCT BEEN USED IN YOUR FACILITY? FOR A FEW MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822667 ↗
• MalfunctionMay 12, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SET FAILED TO WORK PROPERLY, AND THE CLINICIAN WAS UNABLE TO INJECT MEDICATION INTO THE SET. ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER: PLEASE PROVIDE DETAILED PHOTOGRAPHS / VIDEOS OF THE PRODUCT(S)? NOT AVAILABLE. PLEASE CONFIRM THE EXACT LOCATION OF OCCLUSION. SIDE PORTS. PLEASE CONFIRM WHAT SUBSTANCE WAS BEING INFUSED DURING THE TIME OF THE EVENT? MEDICATIONS UNSURE OF WHICH ONES. PLEASE CONFIRM IF THE INFUSATE WAS ALLOWED TO COME TO ROOM TEMPERATURE PRIOR TO INFUSION. IF IT WAS REFRIGERATED? ALL ROOM TEMPERATURE AS FAR AS I KNOW. PLEASE CONFIRM WHEN THE FAULT WAS IDENTIFIED DURING PRIMING OR DURING INFUSION. IF DURING INFUSION, HOW LONG INTO THE INFUSION? NOT DURING PRIMING OF THE LINE BY THE NURSING STAFF, DURING THE USE OF SIDE PORT BY THE ANAESTHETISTS. PLEASE CONFIRM IF THERE IS ANY VISIBLE DAMAGE ON THE SET? NO. PLEASE CONFIRM HOW MANY PRODUCTS ARE AFFECTED. 2. PLEASE CONFIRM IF THERE IS COMPLETE OR PARTIAL OCCLUSION? COMPLETE OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006454 ↗
• MalfunctionMay 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT TWO TUBING'S WHEN CONNECTED TENDS TO COME LOOSE AND SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944300 ↗
• MalfunctionApr 30, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CLINICAL TEAM HAS REPORTED AN ISSUE WITH THE BD SMARTSITE EXTENSION SET (REF: 37262E), LOT NO: 24109419, WITH AN EXPIRY DATE OF 31/10/2027. THEY ARE UNABLE TO INJECT ANY FLUIDS OR MEDICATIONS THROUGH THE SET. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CONFIRM THE EXACT LOCATION OF OCCLUSION. SIDE PORTS. PLEASE CONFIRM WHAT SUBSTANCE WAS BEING INFUSED DURING THE TIME OF THE EVENT? MEDICATIONS UNSURE OF WHICH ONES. PLEASE CONFIRM IF THE INFUSATE WAS ALLOWED TO COME TO ROOM TEMPERATURE PRIOR TO INFUSION IF IT WAS REFRIGERATED? ALL ROOM TEMPERATURE AS FAR AS I KNOW. PLEASE CONFIRM WHEN THE FAULT WAS IDENTIFIED DURING PRIMING OR DURING INFUSION. IF DURING INFUSION, HOW LONG INTO THE INFUSION? NOT DURING PRIMING OF THE LINE BY THE NURSING STAFF, DURING THE USE OF SIDE PORT BY THE ANAESTHETISTS. PLEASE CONFIRM IF THERE IS ANY VISIBLE DAMAGE ON THE SET? NO. PLEASE CONFIRM IF THERE IS COMPLETE OR PARTIAL OCCLUSION? COMPLETE OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939380 ↗
• MalfunctionMar 5, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527165 ↗
• MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. FILTER X2 CRACKED AT LUER CONNECTOR (FEMALE SIDE.) LEAKING MEDICATION INTO BED. FAILED TO REACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21325598 ↗
• MalfunctionSep 17, 2024Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237640 ↗
• MalfunctionApr 26, 2024Leak/Splash; Leak/Splash

  MATERIAL #: UNKNOWN. BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY EXPERIENCE LEAKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. IT HAS BEEN BROUGHT TO OUR ATTENTION THAT EITHER, LAWSON # 133750 IV EXT SET W/2 NEDL FREE SITES REF# 37262E OR LAWSON # 104516 NEEDLE IV AUTOGUARD 22G REF # 382532. IS LEAKING. THEY COULD NOT DUPLICATE THE ISSUE WITH DIFFERENT ITEMS BUT ARE CONCERNED. JUST WANTED YOU TO BE AWARE IN CASE ANY OTHER TEAM MEMBERS ARE REPORTING ISSUES WE ARE EXPERIENCE LEAKING WITH EITHER ITEM # 37262E OR 382532 IN THE ED. CAN YOU PLEASE HELP AT XXXX?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19198287 ↗
• MalfunctionDec 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET WAS DAMAGED AND LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: EXTENSION TUBING FOUND TO BE CRACKED WHERE EXTENSION TUBING AND PRIMARY IV TUBING CONNECT. AS A RESULT, BLOOD BACKFLOWED INTO TUBING AND LEAKED OUT OF CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253662 ↗
• MalfunctionNov 30, 2023Backflow; Backflow

  ADDITIONAL INFORMATION: CUSTOMER RESPONSE: THE LOT NUMBER PROVIDED BY NURSING WAS 1023069391 PERHAPS (10) 23069391. UNFORTUNATELY, THE PACKAGING WAS THROWN AWAY BY NURSING. THEY ALSO DID NOT PROVIDE A DESCRIPTION OF THE DAMAGE/HARM DONE TO PATIENT. ONLY ONE PIECE OF TUBING WAS AFFECTED. JUST LOOKING THROUGH THE BIOHAZARD BAG THAT THE PRODUCT IS IN, I CANNOT SEE ANY DAMAGE. I ALSO DON'T HAVE THAT INFORMATION ON THE PATIENT. SORRY I DON'T HAVE ANY MORE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241798 ↗
• MalfunctionNov 30, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE EXTENSION SET LEAKAGE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: IV TUBING STARTED LEAKING WHILE INFUSING IVF. BLOOD BAKED UP ON THE LINE AND CAUSED A CLOT. IV HAD TO BE REPLACED. DEFECTIVE TUBING REPLACED. SRS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241774 ↗
• MalfunctionMay 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET TUBING SNAPPED OFF AT THE CHAMBER. THIS OCCURRED ONCE EACH IN AN UNSPECIFIED LOT AND LOT 22119067. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ICV TUBING SNAPPED OFF AT CHAMBER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842317 ↗
• MalfunctionApr 14, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THE CONNECTION WAS LOOSE AND LEAKAGE OCCURRED. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿IV TUBING CAME DISCONNECTED FROM THE CHAMBER CASE WHILE PRIMING IV TUBING. THE TUBING IS BD SMARTSITE EXTENSION SET 2 NEEDLE FREE VALUES REF. 37262E ALARIS PRODUCT . THIS IS THE SECOND TIME THIS HAS HAPPENED WITH FLUID FLOWING ALL OVER FLOOR.". WAS THERE ANY HARM OR INJURY TO THE PATIENT, HEALTH CARE PROVIDER, OR ANY OTHER PERSON? NO. WAS THERE A DELAY OF OR CHANGE IN THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE PROVIDE ANY AVAILABLE DETAILS. DELAY IN PROVIDING CARE AS DEALING WITH CLEAN UP AND CONTAINMENT OF FAILURE. IF NOT ANSWERED IN QUESTION #2, WHAT WAS THE MEDICATION ADMINISTERED TO THE PATIENT? NO. IS THE EVENT DATE KNOWN? (B)(6) 2023. IS THE PRODUCT CODE/SKU KNOWN? NO. IS THE LOT NUMBER KNOWN? NO. IS THIS SAMPLE AVAILABLE FOR INVESTIGATION? UNSURE, ATTEMPTING TO OBTAIN IF NOT, IS A PHOTO SAMPLE AVAILABLE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746412 ↗
• MalfunctionApr 12, 2023Crack; Leak/Splash; Loose or Intermittent Connection; Crack; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET HAD STIFF IV TUBING THAT THE CLAMP CRACKED THROUGH. ADDITIONALLY, THE DEFECTIVE TUBING WOULDN'T CONNECT PROPERLY TO THE IV HUB AND CAUSING LEAKAGE. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THAT THE TUBING IS STIFFER, THE CLAMPS HAVE A TENDENCY TO CRACK THE STIFFER TUBING AND THE HUB AT THE END DOESN¿T SCREW ONTO THE IV HUB WELL, THUS LEAKING PROBLEMS. AT TIMES WE GO THRU TWO OR THREE OF THESE EXTENSION SETS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16729012 ↗
• MalfunctionMar 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT 1 BD ALARIS¿ SMARTSITE¿ EXTENSION SET FROM LOT 22089380, AND 4 SETS FROM AN UNSPECIFIED LOT CAME APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD EXTENSION SETS COME APART WHILE IN USE. I HAVE HEARD OF AT LEAST 5 DIFFERENT OCCURRENCES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519122 ↗
• MalfunctionSep 15, 2022Component Missing; Component Missing

  IT WAS REPORTED WHILE USING BD ALARIS SMARTSITE EXTENSION SET THE END CAP WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION TUBING NOTED TO BE MISSING AN END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432367 ↗