BD SmartSite 42521ERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885403274251), received between Nov 21, 2018 and Dec 19, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET HAD PACKAGE OPEN SEAL / STERILITY CONCERNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW PACKAGING WITH THE PERFORATED OPENING. SAYING IT CAN CAUSE CROSS CONTAMINATION IN THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850844 ↗
• MalfunctionMay 9, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SMARTSITE GRAVITY SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: NO FLOW THROUGH SET. WILL HAVE TO GET LOT # FROM (B)(6) DURING YOUR FOLLOW UP. PER (B)(6), 5 OCCURRENCES OVER THE PAST 2 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278614 ↗
• MalfunctionNov 11, 2023Complete Blockage; Complete Blockage

  NO FURTHER INFORMATION WAS PROVIDED. MATERIAL#: 42521E, BATCH#: (10)23069291. IT WAS REPORTED BY CUSTOMER THAT THE TIP OF THE DRIP CHAMBER IS OCCLUDED. THIS HAS HAPPENED ON 2 TUBINGS OF THE SAME LOT. VERBATIM: MATERIAL NO.: 42521E, LOT NO.: (10)23069291. CUSTOMER STATED THAT THE TIP OF THE DRIP CHAMBER IS OCCLUDED. THIS HAS HAPPENED ON 2 TUBINGS OF THE SAME LOT. RCC RECEIVED COMPLAINT VIA PHONE. PIR ATTACHED. ADDITIONAL INFO RECEIVED ON 02-NOV-2023. 1. WHAT IS THE DATE OF THE EVENT? A. MULTIPLE OCCURRENCES. 2. IS THE SAMPLE OR PHOTOGRAPHS AVAILABLE FOR EVALUATION? IF YES, PLEASE PROVIDE SHIPPING ADDRESS FOR SENDING A RETURN LABEL FROM US RCC FOR INVESTIGATION PURPOSES. A. I HAVE THE SAMPLES OF THE TUBING AVAILABLE. (B)(6). 3. WAS THE PRODUCT RECEIVED IN THIS CONDITION? A. YES, THE PRODUCT WAS OCCLUDED COMING OUT OF THE PACKAGE. 4. IF NOT, WHAT WAS THE PRODUCT BEING USED FOR WHEN THE REPORTED ISSUE WAS OBSERVED? A. THE TUBING WAS USED TO HYDRATE A PATIENT BEFORE OR AFTER A SURGICAL PROCEDURE. 5. PLEASE CONFIRM WHETHER OR NOT THERE WAS ANY PATIENT IMPACT. A. NO. 6. WHEN DID THE REPORTED ISSUE HAPPEN? BEFORE USE, DURING USE, AFTER USE? A. THE FIRST INCIDENT WAS REPORTED TO ME ON (B)(6

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117141 ↗
• MalfunctionMay 18, 2023Leak/Splash; Separation Problem; Leak/Splash; Separation Problem

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED COMPONENT SEPARATION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONNECTION POINTS AND NOT TIGHT SO THEY COME APART AND IV FLUIDS AND/OR BLOOD DRIPS FROM THEM WHEN THEY COME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959376 ↗
• MalfunctionAug 18, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE EXPERIENCED COMPONENT SEPARATION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STANDARD BD SMARTSITE GRAVITY IV SET HAVE DEFECTIVE STOPCOCKS THAT WILL NOT TIGHTEN. THEY ARE USED AS THE STANDARD IV SRT ONCOLD LINES IN THE OR. DESPITE TIGHTENING THEY WILL STILL BECOME LOOSE AND CAUSE POTENTIAL HARM TO PATIENT. ON THIS SPECIFIC EVENT I HAD TIGHTENED THE STOPCOCKS PRIOR TO PUSHING INDUCTION MEDICATIONS. THEY APPEARED TO BE SECURELY TIGHTENED. WE HAD PREPPED THE L ARM HIDING THE IV SITE AND TUBING IN THE SAME ARM WE WERE PLACING A LARGE BORE MICRO-PUNCTURE CATHETER. WHILE PLACING THE LINE (NEEDLE IN ARM), WE NOTICED THAT THE IV WAS DRIPPING WELL DESPITE THERE BEING A TOURNIQUET ON THE ARM. WE THEN MOVED THE DRAPE AND NOTICED THE STOPCOCKS HAD DISCONNECTED AND INTRAVENOUS FLUID AND APPROXIMATELY 100CC OF PATIENT'S BLOOD WERE LOST FROM THE IV SET DISCONNECTION. THERE ARE MANY OTHER INSTANCES, MOST DON'T GET PUT INTO OUR QMS SYSTEM. I DON'T HAVE THE PARTICULAR LOT NUMBER BUT AS I SAID IT HAPPENS TOO FREQUENTLY TO BE A ONE TIME MANUFACTURING ISSUE. THERE IS SOME ELEMENT OF DESIGN WHICH PREVENTS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12339021 ↗
• MalfunctionJan 15, 2021Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE TUBING WOULD NOT PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE TUBINGS WOULD NOT PRIME. I CLAMPED THE TUBING, ATTACHED A SYRINGE TO THE MOST PROXIMAL HUB TO THE DRIP CHAMBER AND TRIED TO PULL FLUID FORWARD AND ONLY GOT RESISTANCE. IT APPEARS AS IF THE TUBING IS BLOCKED WHERE IT ATTACHES TO THE DRIP CHAMBER." "THE TUBING HAD BEEN SPIKED INTO AN IV BAG HOWEVER NEVER IN A PATIENT ROOM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11181343 ↗
• MalfunctionNov 2, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE DISCONNECTED AND LOST BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 42521E BATCH NO: UNKNOWN. IT WAS REPORTED THAT A GRAVITY SET BECAME DISCONNECTED WHEN A PATIENT WAS BEING TRANSFERRED, RESULTING IN BLOOD PRODUCT LOST. DR. (B)(6) HAS JUST INFORMED ME OF ANOTHER INCIDENT WITH BD GRAVITY SET. WHEN TRANSPORTING THE PATIENT OVER TO THE PACU, GRAVITY SET BECAME DISCONNECTED AND AS A RESULT, BLOOD PRODUCT WAS LOST. SHE HAS INFORMED ME OF 3 DIFFERENT INSTANCES OF PATIENT CARE CONCERNS DUE TO POOR QUALITY OF PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10775341 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING PRIMING AND PRIOR TO PATIENT USE, A LEAK WAS OBSERVED AS THE DISTAL LUER CONNECTOR OF THE STOPCOCK WOULD NOT TIGHTEN. THE EVENT OCCURRED AT THE REHABILITATION AND ORTHOPEDIC INSTITUTE. AS THIS EVENT OCCURRED DURING PRIMING THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT, AND SUBSEQUENTLY; NO PATIENT HARM OR IMPACT AS A RESULT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9806344 ↗
• MalfunctionFeb 14, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK DISCONNECTS UNINTENTIONALLY FROM THE SET WHILE AN UNSPECIFIED FLUID WAS INFUSING. IT WAS NOTED THAT THE EVENT CAUSED ISSUES WITH CONTAMINATION AND PATIENT CONFIDENCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714699 ↗
• MalfunctionFeb 14, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK DISCONNECTS UNINTENTIONALLY FROM THE SET WHILE AN UNSPECIFIED FLUID WAS INFUSING. IT WAS NOTED THAT THE EVENT CAUSED ISSUES WITH CONTAMINATION AND PATIENT CONFIDENCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714361 ↗
• MalfunctionFeb 14, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK DISCONNECTS UNINTENTIONALLY FROM THE SET WHILE AN UNSPECIFIED FLUID WAS INFUSING. IT WAS NOTED THAT THE EVENT CAUSED ISSUES WITH CONTAMINATION AND PATIENT CONFIDENCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714274 ↗
• MalfunctionFeb 14, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK DISCONNECTS UNINTENTIONALLY FROM THE SET WHILE AN UNSPECIFIED FLUID WAS INFUSING. IT WAS NOTED THAT THE EVENT CAUSED ISSUES WITH CONTAMINATION AND PATIENT CONFIDENCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714272 ↗
• MalfunctionNov 27, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CONNECTIONS IS COMING APART WHICH IS CAUSING SAFETY CONCERNS FOR THE PROVIDERS. THE ANESTHESIOLOGIST THOUGHT HE WAS ADMINISTERING TO THE PATIENT BUT WAS ACTUALLY GOING ON THE FLOOR. STAFF IS HAVING TO TIGHTEN EACH CONNECTION WHICH IS VERY TIME CONSUMING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9383512 ↗
• MalfunctionNov 21, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE CONNECTIONS COMING ARE LOOSE WHICH IS CAUSING SAFETY CONCERNS FOR THE PROVIDERS. STAFF IS HAVING TO TIGHTEN EACH CONNECTION WHICH IS VERY TIME CONSUMING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9353564 ↗
• MalfunctionNov 21, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A GENERAL COMPLAINT WITH NO SPECIFICS THAT THE 3 WAY STOP COCK CONNECTIONS ON INFUSION SETS ARE RANDOMLY LOOSE FROM THE TUBING ALLOWING FOR LEAKAGE OF IV FLUID AND BLOOD. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094533 ↗