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Monoject 1180322100Recalls & reported problems

Cardinal Health, Inc. · 3 mL Syringe with Standard Hypodermic Needle · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521012356), received between Jul 22, 2020 and Jul 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

Device problems

  • Fluid/Blood Leak1
  • Nonstandard Device1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 22, 2020Fluid/Blood Leak; Nonstandard Device; Fluid/Blood Leak; Nonstandard Device

    THE CUSTOMER REPORTED THAT THE HUMAN USE SYRINGE DOES NOT HAVE A TIGHT SEAL AS IT SQUIRTS OUT WHEN END USER APPLIES PRESSURE. ADDITIONAL INFORMATION RECEIVED STATED THAT THE SYRINGES ARE USED PRIMARILY FOR EQUINE BUT OCCASIONALLY FARM DOG/CAT, VACCINES. THE CUSTOMER DESPITE CHECKING/TIGHTENING THE LUER LOCK SEAL, SYRINGES LEAK (SQUIRT OUT AROUND LUER SEAL) WHEN THEY GIVE AN INJECTION SOMETIMES AFTER .4 TO .6 ML OF 1ML HAVE GONE IN THE MUSCLE, THE REST SQUIRTS OUT WITH THE NEEDLE STILL 1" IN THE MUSCLE. SOMETIMES ONLY .1 TO .2 ML GOES IN BEFORE SQUIRTING OUT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10312042 ↗

Other Syringe, piston devices

All Syringe, piston devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.