IV Administration Set 352630Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046955594498), received between Mar 2, 2026 and Mar 20, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: THE DESCRIPTION FOR THIS ITEM SHOWS 10 DROPS PER ML. WE HAD A CUSTOMER COMPLAIN THEY ARE RECEIVING THE WRONG ITEM. THE CATALOG NUMBER MATCHES BUT THE INSIDE PRODUCT SHOWS 15 DROPS PER ML. WE CHECKED ALL OUR STOCK AND FOUND THE SAME ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650396 ↗
• MalfunctionMar 20, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: THE DESCRIPTION FOR THIS ITEM SHOWS 10 DROPS PER ML. WE HAD A CUSTOMER COMPLAIN THEY ARE RECEIVING THE WRONG ITEM. THE CATALOG NUMBER MATCHES BUT THE INSIDE PRODUCT SHOWS 15 DROPS PER ML. WE CHECKED ALL OUR STOCK AND FOUND THE SAME ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650353 ↗
• MalfunctionMar 12, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX. REASON OF COMPLAINT: 352630 WAS MISLABLED AS A 15 DROP SET AND SHOULD BE LABELED AS 10 DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578736 ↗
• MalfunctionMar 11, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX. REASON OF COMPLAINT: 352630 WAS MISLABLED AS A 15 DROP SET AND SHOULD BE LABELED AS 10 DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574493 ↗
• MalfunctionMar 11, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX. REASON OF COMPLAINT: 352630 WAS MISLABLED AS A 15 DROP SET AND SHOULD BE LABELED AS 10 DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567768 ↗
• MalfunctionMar 10, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: PRODUCT LABEL IS INCORRECT. REF: 352630. LOT:0062037053 IS SUPPOSED TO BE 10 DROPS/ML; HOWEVER, IT IS LABELED AS 15 DROPS/ML. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557939 ↗
• MalfunctionMar 10, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX. MISLABELED PRODUCT: 352630 LABELED AT 15 DROP AND SHOULD BE LABELED AS 10 DROP. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557708 ↗
• MalfunctionMar 5, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX: REASON OF COMPLAINT: 352630 WAS MISLABLED AS A 15 DROP SET AND SHOULD BE LABELED AS 10 DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526824 ↗
• MalfunctionMar 5, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX. REASON OF COMPLAINT: 352630 WAS MISLABLED AS A 15 DROP SET AND SHOULD BE LABELED AS 10 DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526711 ↗
• MalfunctionMar 5, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX: REASON OF COMPLAINT: 352630 WAS MISLABLED AS A 15 DROP SET AND SHOULD BE LABELED AS 10 DROP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526640 ↗
• MalfunctionMar 4, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX. INCORRECT ITEM DESCRIPTION OF PRODUCT ON INSIDE OF BOX. END USER COMPLAINED ABOUT RECEIVING THE WRONG PRODUCT ON CATALOG 352630. THE DESCRIPTION ON OUR SITE AND BRAUN SITE STATE "10 DROPS/ML" FOR THIS CATALOG BUT THE DC SAYS THAT THE ACTUAL PRODUCT IN OUR DC IS SHOWING 15 DROPS/ML. THE CATALOG NUMBER MATCHES BUT THE INSIDE PRODUCT SHOWS 15 DROPS PER ML. WE CHECKED ALL OUR STOCK AND FOUND THE SAME ISSUE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510671 ↗
• MalfunctionMar 2, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: ERROR OUT-OF-BOX MISLABELED PRODUCT - 352630 LABELED AT 15 DROP AND SHOULD BE LABELED AS 10 DROP. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489875 ↗
• MalfunctionMar 2, 2026Labelling, Instructions for Use or Training Problem

  AS REPORTED BY THE USER FACILITY: PRODUCT MISLABELED AS 15 DROPS/ML. PRODUCT IS 10 DROPS/ML WHICH IS OUTLINED IN OUR PRODUCT DESCRIPTION AND ON WEBSITE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489741 ↗