AMO ADMINISTRATION SET OM2505191Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474520691), received between Jan 30, 2024 and Aug 22, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Component Missing” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 10 OF 10 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023982 ↗
• MalfunctionAug 21, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 6 OF 10 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023164 ↗
• MalfunctionAug 21, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 5 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017603 ↗
• MalfunctionAug 21, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 8 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015502 ↗
• MalfunctionAug 20, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 7 OF 10 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005450 ↗
• MalfunctionAug 20, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 9 OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003178 ↗
• MalfunctionAug 20, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 10 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002784 ↗
• MalfunctionAug 20, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 3 OF 10 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001534 ↗
• MalfunctionAug 20, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT BD INSYTE AUTOG BC UNABLE TO CONNECT TO LUER CONNECTION AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANGIO 22G LOT NUMBER ENDING IN 9757 ARE NOT SCREWING ON NORMALLY AND THUS CAUSING LEAKING. THEY NOTICED THIS HAPPENED A COUPLE OF TIMES LAST WEEK (IT HAPPED TO ME AS WELL-THOUGH IT WAS USER ERROR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000473 ↗
• MalfunctionAug 20, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 10 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000432 ↗
• MalfunctionJan 30, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMIN SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 4 OF 4 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610849 ↗
• MalfunctionJan 30, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMIN SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 3 OF 4 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610823 ↗
• MalfunctionJan 30, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMIN SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 4 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610750 ↗
• MalfunctionJan 30, 2024Misassembled; Delivered as Unsterile Product; Component Missing; Misassembled; Delivered as Unsterile Product; Component Missing

  IT WAS REPORTED THAT SEVERAL IV ADMINISTRATION SETS HAD LOOSE/MISSING TIPS ON THE LEUR-LOCK END AND CUSTOMER WAS UNABLE TO USE THEM DUE TO STERILITY. THROUGH FOLLOW UP CUSTOMER CONFIRMED THAT THERE WAS A BREACH IN THE STERILE BARRIER. SOME WERE NOTED UPON OPENING THE PRODUCT AND A COUPLE WERE NOTICED BEFORE OPENING, WHILE LOOKING AT THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 4 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610469 ↗