Alaris, SmartSite 10010983Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403233579), received between Sep 1, 2020 and Sep 1, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED WHEN USING THE MICRO EXT SET W/1 SS VLV, THE DEVICE EXPERIENCED AN OCCLUDED, CLOGGED OR BLOCKED PRODUCT. THIS EVENT OCCURRED EIGHT TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BD IDENTIFIED ISSUES WITH VALVE OF THE NEEDLE-FREE CONNECTOR RESULTING IN DIFFICULTY TO FLUSH OR FLOW, WITH PARTIAL OR TOTAL OCCLUSIONS ON EXTENSION SETS WITH NEEDLE-FREE CONNECTORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405170 ↗
• MalfunctionOct 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10010983 LOT NO.: 20055744 IT WAS REPORTED THAT THERE WAS LEAKAGE WITHIN THE TUBING SET. VERBATIM: AT 1400 IT WAS DISCOVERED THAT PATIENT'S PIV WAS LEAKING. UPON CLOSER ASSESSMENT, THE EXTENSION ("T-CONNECTOR") THAT ATTACHES TO THE HUB OF THE IV WAS LEAKING WHERE THE RIGID PART OF THE TUBING NEAR THE VALVE-END MEETS THE FLEXIBLE PORTION OF THE TUBING. THE TUBING EXTENSION WAS ABLE TO BE REPLACED, BUT AFTER REDRESSING THE PIV THE INSERTION SITE STARTED LEAKING. THE IV ULTIMATELY HAD TO BE REMOVED, LEAVING THE PATIENT WITH NO WAY TO RECEIVE INCOMPATIBLE MEDS OR BLOOD PRODUCTS. VAT TEAM CALLED TO ASSESS FOR NEW IV SITE, BUT NONE FOUND. PICC TEAM CONSULTED, BUT UNABLE TO PLACE UNTIL TOMORROW AM. PICU TEAM AWARE. THE IV AND EXTENSION WERE 5 WEEKS OLD. THE IV GOING BAD WAS LIKELY AT THIS POINT, REGARDLESS, AND DISCUSSIONS COULD HAVE BEEN HAD REGARDING OBTAINING MORE RELIABLE ACCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694549 ↗
• MalfunctionOct 17, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV TUBING WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 1001983 LOT NO.: 20055744. IT WAS REPORTED THAT THERE WAS AN OCCLUSION WITHIN THE TUBING SETS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694548 ↗
• MalfunctionOct 17, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV TUBING WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10010983, LOT NO: 20055744. IT WAS REPORTED THAT THERE WAS AN OCCLUSION WITHIN THE TUBING SETS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694547 ↗
• MalfunctionOct 17, 2020Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV TUBING HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10010983 LOT NO.: 20055744. IT WAS REPORTED THAT THERE WAS AN OCCLUSION WITHIN THE TUBING SETS. VERBATIM: I WAS TRYING TO DRAW BLOOD FROM MY PT'S PICC LINE. IT FLUSHED WELL. I WAS ABLE TO DRAW UP MY WASTE WITHOUT DIFFICULTY. BUT THEN IT STARTED DRAWING UP AIR INTO MY 3ML SYRINGE. IT FILLED THE ENTIRE T-PIECE WITH AIR. I DID NOT WANT TO FLUSH THE AIR INTO MY PATIENT SO I LEFT EVERYTHING AS IT WAS AND PAGED IV THERAPY TO COME ASSESS THE LINE IMMEDIATELY. WHEN IV THERAPY NURSE TOOK DOWN THE DRESSING, THERE WAS NO VISIBLE CRACK, HOLE OR LOOSE CONNECTION. THE BLUE PART OF THE PICC LINE (CATHETER) IS FILLED WITH BLOOD ALL THE WAY UP TO THE HUB. SHE DISCARDED THE OLD T-PIECE AND REPLACED WITH A NEW ONE THAT WAS FLUSHED WITH SALINE. HOWEVER, THE LINE NOW WOULD NOT FLUSH OR DRAW SO SHE HAD TO TPA THE LINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694546 ↗
• MalfunctionOct 17, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV TUBING WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10010983. LOT NO.: 20055744. IT WAS REPORTED THAT THERE WAS AN OCCLUSION WITHIN THE TUBING SETS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694545 ↗
• MalfunctionSep 1, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MICRO EXT SET W/1 SS VLV WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10010983, BATCH(LOT) NO: 20055744. IT WAS REPORTED THAT BD SMART SITES HAVE BEEN DEFECTIVE (UNKNOWN REASON-PENDING CUSTOMER RESPONSE). I AM REACHING OUT BECAUSE A NURSE MANAGER IN OUR VASCULAR ACCESS DEPARTMENT HAS REACHED OUT ABOUT PRODUCT 10010983 (BD SMART SITES). THEY HAVE RECENTLY BEEN DEFECTIVE AND I HAVE BEEN RECEIVING REPORTS FOR LOT NUMBER 20055744.

  Patient problems: No Patient Involvement

  MAUDE report 10477747 ↗