SmartSite MV0520Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10885403228117), received between Aug 25, 2017 and Dec 20, 2022 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DOXORUBICIN LEAKED FROM THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ONCOLOGY TECHNICIAN HAS BROUGHT TO MY ATTENTION THAT THE TEXIUM NEEDLE FREE SYRINGE IS EXPERIENCING SOME LEAKING/DRUG EXPOSURE WHEN USING. RECENTLY, DOXORUBICIN WAS USED AND THE DRUG CAN CLEARLY BE SEEN (SINCE DRUG IS RED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019494 ↗
• MalfunctionSep 24, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE EXPERIENCED OCCLUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE LEAD CHEMO TECH WAS PREPARING MEDICATION AND EXPERIENCED PLUNGER MOVEMENT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481093 ↗
• MalfunctionSep 24, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE EXPERIENCED COMPONENT SEPARATION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAD CHEMO TECH EXPERIENCED BREAKAGE OF THE SYRINGE LUER TIP THAT RESULTED IN LEAKAGE OF THE CHEMOTHERAPY MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480635 ↗
• MalfunctionMay 21, 2022Defective Device; Defective Device

  IT WAS REPORTED BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 20MM HAD FLUID DRAWN INTO THE VENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST CALLED AND WHILE PREPARING CHEMOTHERAPY THE FLUID WAS DRAWN INTO THE VENT AND MEDICATION DURING USE WITH THE ACCESS ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465124 ↗
• MalfunctionMar 23, 2022Backflow; Defective Component; Backflow; Defective Component

  IT WAS REPORTED BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 20MM HAD FLOW ISSUES AND WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BCG STARTS TO GO IN VIA THE CATHETER AND THEN IT STOPS AND STARTS BACKFLOWING BACK INTO THE SODIUM CHLORIDE BOTTLE ON US... ONE OF THE NURSES WHO REPORTED THE FLOW CONCERNS ALSO MENTIONED DIFFICULTY SEATING THE VIALSHIELD ON THE NSS VIAL. SHE STATED THAT SHE HAS OBSERVED THAT THE PLASTIC INSERTION TIP SOMETIMES APPEARS TO BE BENT AFTER BEING PUSHED INTO THE NSS VIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865288 ↗
• MalfunctionDec 10, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SMARTSITE VIALSHIELD 20MM CLOSED VAD EXPERIENCED COMPONENT SEPARATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TEXTIUM VIAL TOPPER BROKE WHEN ATTEMPTING TO DISCONNECT THE SYRINGE. VERBATIM: EARLIER TODAY WE HAD A SITUATION WHERE THE AN MV-20 TEXIUM VIAL TOPPER BROKE WHEN ATTEMPTING TO DISCONNECT THE TEXIUM SYRINGE FROM THE VIAL TOPPER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10989260 ↗
• MalfunctionNov 2, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SMARTSITE VIALSHIELD 20MM CLOSED VAD HAD FOREIGN MATTER IN THE EXPANSION CHAMBER.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES THAT TEXIUM VENTED VIAL ADAPTER HAS SOME TYPE OF FOREIGN MATTER WHICH LOOKS LIKE A BLACK SPECK INSIDE THE EXPANSION CHAMBER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10775347 ↗
• MalfunctionAug 18, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SMARTSITE VIALSHIELD 20MM CLOSED VAD EXPERIENCED LEAKAGE, COMPONENT SEPARATION, AND DEVICE DAMAGE/DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAREFUSION VIALSHIELD 20 MM DEVICE IS PART OF A CLOSED SYSTEM TRANSFER DEVICE TO BE USED IN THE PREPARATION OF CHEMOTHERAPY IN A PHARMACY THE CONNECTIONS ON THE DEVICE ARE SUPPOSED TO BE SEALED BY GLUE AND WERE SEPARATING ONCE A SYRINGE WAS ATTACHED THIS OCCURRED WITH 2 PRODUCTS AND A 3RD ONE BROKE AT THE CONNECTION AND LEAD TO A SMALL CHEMO SPILL STAFF WAS INSTRUCTED TO HOLD DEVICE AT THE CONNECTION TO ASSUME IT WASN'T SEALED AT MANUFACTURER'S PRODUCT WAS INTENDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423111 ↗
• MalfunctionJul 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SMARTSITE VIALSHIELD 20MM CLOSED VAD LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MV0520 BATCH(LOT) NO: UNKNOWN- CUSTOMER REPORTED LOT # IS (10)9294 IT WAS REPORTED THAT ADAPTOR LEAKED FROM AN UNKNOWN LOCATION. TECHNICIAN WAS DRAWING UP FLUOROURACIL USING A 20 MM VIAL ADAPTOR (MV0520) AND DRUG STARTED LEAKING FROM THE VIAL ADAPTOR AT AN UNDETERMINED LOCATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273763 ↗
• MalfunctionJul 13, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SMARTSITE VIALSHIELD 20MM CLOSED VAD LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: MV0520 BATCH NO: UNKNOWN. IT WAS REPORTED, THAT THE VIAL ADAPTOR LEAKS AT AN UNDETERMINED LOCATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10267786 ↗
• MalfunctionMay 14, 2020Fluid/Blood Leak; Dent in Material; Fluid/Blood Leak; Dent in Material

  IT WAS REPORTED THAT IN THE PHARMACY THE CLINICIAN WAS USING A TEXIUM VIALSHIELD. WHILE SHAKING THE DILUENT WITH THE TEXIUM VIALSHIELD STILL ATTACHED IT WAS NOTICED THAT DROPS OF FLUID WERE LEAKING FROM THE VIAL. A COWORKER TOOK A CLOSER LOOK AT THE VIAL AND THE ADAPTOR AND SAW THAT THERE WAS A DENT IN THE METAL COAT AROUND THE RUBBER STOPPER. THIS CAUSED THE DEVICE NOT TO SIT PROPERLY ON THE VIAL, WHICH CAUSED THE LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10057362 ↗
• MalfunctionApr 7, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE CLOSED VIAL ACCESS DEVICE (CVAD) SEPARATED WHILE THE PHARMACY TECHNICIAN WAS UNSCREWING THE TEXIUM SYRINGE FROM THE CVAD ATTACHED TO RITUXIMAB VIAL. THE LEAK DID NOT CAUSE HARM TO THE PHARMACY TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED WHILE THE MEDICATION WAS BEING PREPARED IN THE PHARMACY DEPARTMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9933436 ↗
• MalfunctionFeb 21, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE CLOSED VIAL ACCESS DEVICE (CVAD), ATTACHED TO A PACLITAXEL 50ML VIAL, SEPARATED WHILE THE PHARMACY TECHNICIAN WAS UNSCREWING THE TEXIUM SYRINGE FROM THE CVAD. THE LEAK DID NOT CAUSE HARM TO THE PHARMACY TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED WHILE THE MEDICATION WAS BEING PREPARED IN THE PHARMACY DEPARTMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9740150 ↗
• MalfunctionFeb 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CLOSED VIAL ACCESS DEVICE (CVAD) HAS A LEAKING ISSUE. THE ISSUE WAS NOTED WHILE THE PHARMACIST WAS PREPARING AN UNSPECIFIED HAZARDOUS MEDICATION. THE ISSUE OCCURRED TWICE ON (B)(6) 2020. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED IN THE PHARMACY DEPARTMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9728001 ↗
• MalfunctionFeb 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CLOSED VIAL ACCESS DEVICE (CVAD) HAS A LEAKING ISSUE. THE ISSUE WAS NOTED WHILE THE PHARMACIST WAS PREPARING AN UNSPECIFIED HAZARDOUS MEDICATION. THE ISSUE OCCURRED TWICE ON (B)(6), 2020. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED IN THE PHARMACY DEPARTMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9727999 ↗
• MalfunctionFeb 6, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE CLOSED VIAL ACCESS DEVICE (CVAD) ATTACHED TO AZACITADINE VIAL SEPARATED WHILE THE PHARMACY TECHNICIAN WAS UNSCREWING THE TEXIUM SYRINGE FROM THE CVAD. THE LEAK DID NOT CAUSE HARM TO THE PHARMACY TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED WHILE THE MEDICATION WAS BEING PREPARED IN THE PHARMACY DEPARTMENT.. THE CUSTOMER PROVIDED PHOTO OF THE PRODUCT.

  Patient problems: No Patient Involvement

  MAUDE report 9675010 ↗
• MalfunctionJan 27, 2020Break; Break

  IT WAS REPORTED THAT THE INJECTION PORT BROKE OFF OF THE ADAPTOR WHEN ATTEMPTING TO DRAWN MEDICATION OUT OF THE VIAL. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 9631864 ↗
• MalfunctionNov 13, 2019Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT WHILE DETACHING A SYRINGE FROM A FLUOROURACIL VIAL, THE "BLUE PART" ORIGINALLY ATTACHED TO THE SPIKE "FELL OFF." IT WAS REPORTED THAT THIS CAUSED A DELAY IN THE PREPARATION PROCESS AND CREATED A SPILL AND VAPORS COMING FROM THE FLUOROURACIL VIAL. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO THE USER.

  Patient problems: No Patient Involvement

  MAUDE report 9318406 ↗
• MalfunctionNov 13, 2019Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT WHILE DETACHING A SYRINGE FROM A FLUOROURACIL VIAL, THE "BLUE PART" ORIGINALLY ATTACHED TO THE SPIKE "FELL OFF." IT WAS REPORTED THAT THIS CAUSED A DELAY IN THE PREPARATION PROCESS AND CREATED A SPILL AND VAPORS COMING FROM THE FLUOROURACIL VIAL. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO THE USER.

  Patient problems: No Patient Involvement

  MAUDE report 9318404 ↗
• MalfunctionNov 12, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA, WHICH STATES: "DEFECTIVE SMART SITE VIAL SHIELD- DURING THE WITHDRAWAL OF A DRUG FROM A VIAL USING THE CSTD, THE TOP SNAPPED OFF (WHITE TOP PIECE) CONSEQUENTLY REMOVING THE BLUE INTERNAL PIECE AS WELL. SMALL CHEMOTHERAPY SPILL OCCURRED DURING THIS MIXING PROCESS FDA SAFETY REPORT".

  Patient problems: No Information

  MAUDE report 9312861 ↗
• MalfunctionJun 28, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE VIALSHIELD SPIKE CORES STOPPER PIECES OF BRAND WG CRITICAL CARE PACLITAXEL INTO THE DRUG VIAL WHILE PREPARING IN THEIR PHARMACY 50% OF THE TIME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Chemical Exposure

  MAUDE report 8746067 ↗
• MalfunctionJun 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE LEAKAGE OF DRUG WHEN TRANSFERRING ERBITUX (CETUXIMAB) AND PACTIAXEL FROM A TEXIUM NEEDLE-FREE SYRINGE TO THE TEXIUM FILTER LINE. THIS HAPPENS TO APPROXIMATELY 35% OF THE TIME OVER 5 YEARS WHILE ERBITUX BAGS THEY PREPARE IN THEIR PHARMACY. THERE WAS NO PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734967 ↗
• MalfunctionJun 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VISIBLE RESIDUE OF HAZARDOUS DRUGS ON CONNECTING SURFACES UPON DISCONNECTION WHEN THEY PREPARE CHEMO IN THEIR PHARMACY 90-100% OF THE TIME EVERY DAY FOR THE PAST 5 YEARS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733060 ↗
• MalfunctionAug 25, 2017Device Contamination with Chemical or Other Material

  TODAY WE FOUND ONE OF OUR CAREFUSION 20MM CLOSED VIAL ACCESS DEVICE (MV0520 SMARTSITE VIALSHIELD) WITH SMALL PIECES OF GRAY OR BLACK PARTICULATE MATTER SEALED BETWEEN THE FLEXIBLE DIAPHRAGM AND THE HARD WHITE PLASTIC RESERVOIR. THE PARTICLE MIGHT BE ABLE TO ENTER THE VIAL AS IT IS BEING RECONSTITUTED. THE LOT NUMBER IS 6238, AND THE EXPIRATION DATE OF THE PRODUCT IS 11/28/2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6820526 ↗