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Alaris, SmartSite 42133ERecalls & reported problems

BD Switzerland Sàrl · Gravity Set, 2 Needle-Free Valves Vented/ Nonvented 264 cm (104 in) · Class 2

All models of Alaris, SmartSite (160)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613203020916), received between Sep 25, 2023 and Sep 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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

Device problems

  • Component Missing3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2023Component Missing; Component Missing

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 42133E. BATCH#: 23019320. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD SEVERAL OF THESE 42133E THAT ARE MISSING THE NEEDLE INSIDE THE TUBE. VERBATIM: CUSTOMER REPORTED HAVE HAD SEVERAL OF THESE 42133E THAT ARE MISSING THE NEEDLE INSIDE THE TUBE. RESPONSE RECEIVED ON 14-SEP-2023. ARE YOU ABLE TO ADVISE THE DATE OF EVENT? (B)(6) 2023. PLUS OTHER DAYS THAT WAS NOT REPORTED TO ME. WHAT IS THE TOTAL QUANTITY OF AFFECTED TUBING? - OVER 20. IS THERE SAMPLE AVAILABLE TO RETURN FOR INVESTIGATION? - YES. WAS THE ISSUE NOTICED WHEN THE PRODUCT WAS TAKEN OUT OF PACKAGE? YES - IV TUBING WAS FLOWING TO FAST AND WAS FOUND TO BE DEFECTIVE. WAS THERE ANY PATIENT INVOLVEMENT? - YES. IF YES, WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO. RESPONSE RECEIVED ON 18-SEP-2023. WERE ANY OF THE EVENTS IDENTIFIED DURING PRIMING OF THE TUBING? - YES, THE THIRD OCCURRENCE. WERE ANY OF THE DEFECTIVE TUBING USED ON PATIENTS? - YES. PLEASE DESCRIBE WHAT THE PATIENT INVOLVEMENT WAS. - THE TUBING WAS USED ON TWO PEDIATRIC PATIENTS THAT WERE HAVING DENTAL SURGERY. THE TUBING WAS CHANGED OUT AFTER THE SURGERY WAS STARTED ON BOTH CASES. ONE CASE THE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17814692 ↗
  • MalfunctionSep 25, 2023Component Missing; Component Missing

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 42133E, BATCH#: 23019320. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD SEVERAL OF THESE 42133E THAT ARE MISSING THE NEEDLE INSIDE THE TUBE. VERBATIM: CUSTOMER REPORTED HAVE HAD SEVERAL OF THESE 42133E THAT ARE MISSING THE NEEDLE INSIDE THE TUBE. RESPONSE RECEIVED ON 14-SEP-2023. ARE YOU ABLE TO ADVISE THE DATE OF EVENT? 8/18/2023, 8/28/2023 PLUS OTHER DAYS THAT WAS NOT REPORTED TO ME. WHAT IS THE TOTAL QUANTITY OF AFFECTED TUBING? - OVER 20. IS THERE SAMPLE AVAILABLE TO RETURN FOR INVESTIGATION? - YES. WAS THE ISSUE NOTICED WHEN THE PRODUCT WAS TAKEN OUT OF PACKAGE? YES - IV TUBING WAS FLOWING TO FAST AND WAS FOUND TO BE DEFECTIVE. WAS THERE ANY PATIENT INVOLVEMENT? - YES. IF YES, WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO. RESPONSE RECEIVED ON 18-SEP-2023. WERE ANY OF THE EVENTS IDENTIFIED DURING PRIMING OF THE TUBING? - YES, THE THIRD OCCURRENCE. WERE ANY OF THE DEFECTIVE TUBING USED ON PATIENTS? - YES. PLEASE DESCRIBE WHAT THE PATIENT INVOLVEMENT WAS. - THE TUBING WAS USED ON TWO PEDIATRIC PATIENTS THAT WERE HAVING DENTAL SURGERY. THE TUBING WAS CHANGED OUT AFTER THE SURGERY WAS STARTED ON BOTH CASES. ONE C

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17814690 ↗
  • MalfunctionSep 25, 2023Component Missing; Component Missing

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 42133E, BATCH#: 23019320. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD SEVERAL OF THESE 42133E THAT ARE MISSING THE NEEDLE INSIDE THE TUBE. VERBATIM: CUSTOMER REPORTED HAVE HAD SEVERAL OF THESE 42133E THAT ARE MISSING THE NEEDLE INSIDE THE TUBE. RESPONSE RECEIVED ON 14-SEP-2023. ARE YOU ABLE TO ADVISE THE DATE OF EVENT? 8/18/2023, 8/28/2023 PLUS OTHER DAYS THAT WAS NOT REPORTED TO ME. WHAT IS THE TOTAL QUANTITY OF AFFECTED TUBING? - OVER 20. IS THERE SAMPLE AVAILABLE TO RETURN FOR INVESTIGATION? - YES. WAS THE ISSUE NOTICED WHEN THE PRODUCT WAS TAKEN OUT OF PACKAGE? YES - IV TUBING WAS FLOWING TO FAST AND WAS FOUND TO BE DEFECTIVE. WAS THERE ANY PATIENT INVOLVEMENT? - YES. IF YES, WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED? NO. RESPONSE RECEIVED ON 18-SEP-2023. WERE ANY OF THE EVENTS IDENTIFIED DURING PRIMING OF THE TUBING? - YES, THE THIRD OCCURRENCE. WERE ANY OF THE DEFECTIVE TUBING USED ON PATIENTS? - YES. PLEASE DESCRIBE WHAT THE PATIENT INVOLVEMENT WAS. - THE TUBING WAS USED ON TWO PEDIATRIC PATIENTS THAT WERE HAVING DENTAL SURGERY. THE TUBING WAS CHANGED OUT AFTER THE SURGERY WAS STARTED ON BOTH CASES. ONE C

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17814689 ↗

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