BD SmartSite 42081ERecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613203020855), received between Sep 18, 2018 and Sep 18, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Oct 11, 2023Open, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0350-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831246 ↗
• MalfunctionSep 18, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831237 ↗
• MalfunctionSep 18, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831236 ↗
• MalfunctionSep 18, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831235 ↗
• MalfunctionDec 23, 2025Difficult to Insert; Difficult to Insert

  YES, WE HAVE HAD ISSUES W/ THE XXX SPIKES GETTING STUCK IN THE UNITS¿ ¿SPIKE PORT¿ WHEN SWITCHING OUT BAGS OF PLASMA AND RED CELLS DURING APHERESIS PROCEDURES (NO ISSUES W/ USING ON ALBUMIN BOTTLES). THIS WAS CAUSING US TO HAVE TO LOSE A NICE AMOUNT OF A UNIT BECAUSE THE SPIKES WOULDN¿T COME OUT AND SO TUBING NEEDED TO BE CHANGED OFTEN. APPARENTLY, THIS HAD HAPPENED FREQUENTLY W/ THIS BRAND OF TUBING (XXX) WHICH CAUSED US TO CONTINUE ORDERING XXX TUBING, AS WE HAVE NO ISSUES W/ SPIKES GETTING STUCK W/ THIS BRAND. I HAVE ASKED THE NURSES TO ATTEMPT TO USE THE XXX BRAND TO SEE IF THE ISSUE WE HAD IN THE PAST HAS BEEN RESOLVED W/ THESE SPIKES. MANY ARE APPREHENSIVE AS THEY RECALL THE ISSUES FROM BEFORE. SO FAR, ONE PROCEDURE HAS BEEN COMPLETED W/O ISSUE ON PLASMA UNITS¿ WE WILL SEE IF THEY WORK WELL W/ RBCS AS WELL¿ AND I GUESS WE WILL GO FROM THERE. IF WE CAN MAKE XXX WORK, WE WILL DEFINITELY USE THEM, BUT IF WE RUN INTO THE SAME COMPLICATIONS W/ THE SPIKES, WE MAY NEED TO RESUME THE XXX TUBING SEARCH. ON (B)(6) 2025: THE ISSUES W/ BD BLOOD TUBING OCCURRED A FEW YEARS BACK WHEN THE SYSTEM FIRST TRIALED THE BD TUBING. AT THAT TIME, D/T THE DIFFICULTY IN CHANGING BLOOD PRODUCT UNITS (S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877127 ↗
• MalfunctionDec 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS GRAVITY SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT WAS LEAKING FLUIDS FROM THE LINE.

  Patient problems: Insufficient Information

  MAUDE report 23780895 ↗
• MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. "FROM RN: BLOOD TUBING PRIMED WITH NORMAL SALINE BAG. AFTER SPIKING BLOOD PRODUCT AND OPENING ROLLER CLAMP I NOTICED BLOOD LEAKING FROM BIFURCATION ABOVE THE FILTER. I RECLAMPED THE BLOOD PORTION AND REPLACED THE TUBING WITH GRAVITY HAND PUMP TUBING WITHOUT INCIDENT. ~10-20 CC OF BLOOD WAS LOST TO FLOOR AND DEFECTIVE TUBING. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21324787 ↗
• MalfunctionMay 15, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY BLOOD SET WAS MISSING A COMPONENT THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: VERBATIM: GRAVITY SET IS SUPPOSED TO HAVE 3 ROLLER CLAMPS BUT IT ONLY HAS 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324051 ↗
• MalfunctionJul 14, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY BLOOD SET TUBING CLAMP WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THE TUBING IS MISSING A CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329893 ↗
• MalfunctionMay 18, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY BLOOD SET TUBING WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POSSIBLE CRACKED TUBING. BLOOD LEAKING FROM TUBING INSERTION SITE GOING INTO GGT CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959331 ↗
• MalfunctionOct 21, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ SMARTSITE¿ GRAVITY BLOOD SETS HAD FLOW ISSUES AND WERE BLOCKED DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE J-LOOPS FOR I/VS ARE NOT BEING PATENT. WHEN THEY HOOK THEM UP, YOU CANNOT FLUSH FLUIDS THROUGH THEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15653265 ↗
• MalfunctionSep 28, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED THAT THE TUBING DOES NOT ALLOW THE BLOOD TO FLOW WELL THROUGH THE SET AND THE BLOOD SLOWS DOWN ALMOST TO A STOP AND THEY HAVE TO CHANGE TUBING IN THE MIDDLE OF ADMINISTRATIONS. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919361 ↗
• MalfunctionSep 18, 2018Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE MICRON FILTER IN THE GRAVITY NON-VENTED BLOOD SET COLLAPSED WHEN ADMINISTRATING BLOOD QUICKLY WITH A UNSPECIFIED SYRINGE. THE EVENT OCCURRED IN THE CT (CARDIOTHORACIC) OR. RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM THE FDA WHICH STATES "THE FILTER ON THE CAREFUSION GRAVITY BLOOD TUBING 42081E COLLAPSES WHEN USING A SYRINGE METHOD TO QUICKLY ADMINISTER BLOOD DURING CARDIAC SURGERY. AND THE DRIP CHAMBER IS DIFFICULT TO FILL CAUSING AIR TO GET INTO THE LINE IF ADMINISTERING BLOOD EMERGENTLY¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887823 ↗
• MalfunctionSep 18, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT THE BLOOD TUBING CAME APART AT THE SPIKE WHEN ADMINISTRATING BLOOD. RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM THE FDA WHICH STATES "THE TUBING AT THE SPIKE CONNECTION FOR THE CAREFUSION GRAVITY BLOOD TUBING CAME APART." "BLOOD ADMINISTRATION DURING CT SURGERY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887799 ↗