SmartSite 20350ETRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885403229756), received between Mar 23, 2020 and May 5, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

2 FDA recall records name this device's identifier, 2 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. May 12, 2025Open, Classified

   Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.

   Z-1970-2025 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 11, 2023Open, Classified

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

   Z-0351-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS TEXIUM SMARTSITE LOW SORBING EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT TEXIUM BONDED SET LEAKED UPON EITHER CONNECTION OR DISCONNECTION TO SMARTSITE. DRUG LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963391 ↗
• MalfunctionApr 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. I HAVE REPRESENTATIVE SAMPLES, IN PACKAGE, NOT THE ONES INVOLVED WITH THE PATIENT. I MET WITH XXXX AND HER STAFF-- WHILE BEING ON SITE AND LOOKING AT TEXIUM, HOW THINGS OCCURRED WITH RECENT PIR'S (2 WEEKS AGO) THE NURSE NOTICED HER GLOVED BEING WET--LOOKED LIKE THE MED (NOT HAZARDOUS) WAS "SEEPING" WHERE THE TEXIUM CONNECTION (BINDED TO THE 203050ET FILTER SET ) TO THE 2000E SMARTSITE---STAND ALONE SMART SITE ATTACHED TO A FEMALE LUER OF A PORT ACCESS NEEDLE. 6-7 INFUSIONS OCCURRING ON OTHER PATIENTS SOME WITH MULTIPLE TEXIUM IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862419 ↗
• MalfunctionMar 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS TEXIUM SMARTSITE LOW SORBING EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. VERBATIM: THE TUBING WITH REF #(B)(4) BD LOW SORBING EXTENSION SET 0.2 MICRON LOW PROTEIN BINDING FILTER IS LEAKING AT THE POINT OF CONNECTION. IT IS A TRACE AMOUNT, BUT IT IS LEAKING. WE HAVE BEEN ATTACHING THE FILTER TUBING TO THE END OF THE CHEMO TUBING SO IT IS ATTACHED CLOSER TO THE PATIENT, BUT I HAD A PATIENT WHO HAD A SMALL WET SPOT ON HIS SHIRT DURING THE INFUSION. I WAS ABLE TO GET HIM CLEANED UP AND WRAPPED THE TEXIUM LUER WITH GAUZE AND TAPE TO PREVENT ANY MORE CHEMO GETTING ONTO THE PATIENT AND WE WERE ABLE TO COMPLETE THE INFUSION. IT HAPPENED AGAIN TODAY. I ATTACHED THE FILTER TUBING TO THE BOTTOM OF THE SECONDARY LINE TO KEEP IT AWAY FROM THE PATIENT AND WHEN I WENT TO CHECK THE LINES, THERE WAS AGAIN A SMALL AMOUNT OF WETNESS AT THE CONNECTION SITE. I HAVE ATTACHED A PHOTO OF THE HOOK UP TODAY WITH AN ARROW SHOWING WHERE THE LEAKING IS HAPPENING. I AGAIN WRAPPED THE TEXIUM LUER WITH GAUZE AND TAPE AND WAS ABLE TO FINISH THE INFUSION. THERE WAS NO LIQUID NOTED ON THE FLOOR OR ACTIVELY DRIPPI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21639188 ↗
• MalfunctionMar 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS TEXIUM SMARTSITE LOW SORBING EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM VERBATIM: THE TUBING WITH REF #20350ET BD LOW SORBING EXTENSION SET 0.2 MICRON LOW PROTEIN BINDING FILTER IS LEAKING AT THE POINT OF CONNECTION. IT IS A TRACE AMOUNT, BUT IT IS LEAKING. WE HAVE BEEN ATTACHING THE FILTER TUBING TO THE END OF THE CHEMO TUBING SO IT IS ATTACHED CLOSER TO THE PATIENT, BUT I HAD A PATIENT WHO HAD A SMALL WET SPOT ON HIS SHIRT DURING THE INFUSION. I WAS ABLE TO GET HIM CLEANED UP AND WRAPPED THE TEXIUM LUER WITH GAUZE AND TAPE TO PREVENT ANY MORE CHEMO GETTING ONTO THE PATIENT AND WE WERE ABLE TO COMPLETE THE INFUSION. IT HAPPENED AGAIN TODAY. I ATTACHED THE FILTER TUBING TO THE BOTTOM OF THE SECONDARY LINE TO KEEP IT AWAY FROM THE PATIENT AND WHEN I WENT TO CHECK THE LINES, THERE WAS AGAIN A SMALL AMOUNT OF WETNESS AT THE CONNECTION SITE. I HAVE ATTACHED A PHOTO OF THE HOOK UP TODAY WITH AN ARROW SHOWING WHERE THE LEAKING IS HAPPENING. I AGAIN WRAPPED THE TEXIUM LUER WITH GAUZE AND TAPE AND WAS ABLE TO FINISH THE INFUSION. THERE WAS NO LIQUID NOTED ON THE FLOOR OR ACTIVELY DRIPPI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21639187 ↗
• MalfunctionJan 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS TEXIUM SMARTSITE LOW SORBING EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM:WE HAVE EXPERIENCED ANOTHER INCIDENT OF PRECIPITATION IN THE LOW SORBING TEXIUM TUBING(24601-B007T) AS WELL AS THE 0.2 MICRON FILTER WITH TEXIUM(20350ET) DURING A 24 HOUR PACLITAXEL INFUSION. I DO NOT HAVE THE LOTS AVAILABLE TO ME, BUT ATTACHED ARE PHOTOS OF THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423544 ↗
• MalfunctionJun 9, 2023Component Missing; Component Missing

  IT WAS REPORTED THERE WERE 2 OCCURRENCES OF OPENING BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER THAT THE END CAP WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 OF THE IN-LINE FILTER OPENED TODAY HAVE NO WHITE CAP ATTACHED AT THE END OF THE LINE. PICTURE SHOWN IS ONE OF THEM, WE HAVE A TOTAL OF 2. NAME OF THE IN-LINE FILTER IS BD LOW SORBING EXTENSION SET (0.2 MICRON LOW PROTEIN BINDING FILTER), REF (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17095862 ↗
• MalfunctionMay 19, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD SMARTSITE¿ EXTENSION SET THE COMPONENTS SEPARATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE OPENED A NEW IN-LINE FILTER YESTERDAY 4/25/2023, AND IT CAME BROKEN AROUND THE DISCS AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962170 ↗
• MalfunctionMay 11, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED, WHILE USING BD ALARIS SECONDARY SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLED TO REPORT, THAT ON 04/18/23. THEY MADE A CHEMO TAXOL BAG, FOR A PATIENT AT THE (B)(6) CLINIC AND THE FILTER IS LEAKING. SHE IS NOT SURE, IF THERE IS A CRACK AROUND THE FILTER AREA. PRODUCT 20350ET, EXTENSION SET W/.2MF, SMARTSITE & TEXIUM. PHONE (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916736 ↗
• MalfunctionApr 16, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD ALARIS¿ TEXIUM¿ SMARTSITE¿ LOW SORBING EXTENSION SET LINE DETACHED FROM THE FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON THE EXTENSION SET THE BLUE LINE WAS DETACH FROM THE WHITE FILTER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748693 ↗
• MalfunctionSep 27, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EXTENSION SET W/.2MF, SMARTSITE & TEXIUM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER HAS THE DEFECTIVE SET HOWEVER IT HAS CHEMO IN IT. IT LEAKED WHERE THE TUBING MEETS/IS FUSED WITH THE FILTER.

  Patient problems: No Patient Involvement

  MAUDE report 10591200 ↗
• MalfunctionMar 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET LEAKED FROM THE ROUND DISK ON THE FILTER DURING PRIMING OF NORMAL SALINE, BEFORE IT WAS CONNECTED TO THE PATIENT. EVENT OCCURRED IN OUTPATIENT INFUSION CENTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9868232 ↗
• MalfunctionMar 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET LEAKED FROM THE ROUND DISK ON THE FILTER DURING PRIMING OF NORMAL SALINE, BEFORE IT WAS CONNECTED TO THE PATIENT. EVENT OCCURRED IN OUTPATIENT INFUSION CENTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9866023 ↗