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Magellan 8881833115 (UDI 10192253024708)Recalls & reported problems

Cardinal Health 200, LLC · 3 mL Syringe with Hypodermic Safety Needle 21G x 1.5 in.(0.8 x 38 mm) · Class 2

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 10192253024708), received between Nov 4, 2021 and Nov 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Crack3
  • Fluid/Blood Leak2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Unspecified Mental, Emotional or Behavioral Problem1

Recent adverse event reports

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

  • MalfunctionNov 16, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE HUB CRACKED DURING DIRECT PATIENT CARE WHILE ADMINISTERING ANTIPSYCHOTIC INJECTIONS. THE PATIENT RECEIVED AN UNKNOWN AMOUNT OF MEDICATION (HALDOL). AS THE HALDOL WAS BEING ADMINISTERED IT LEAKED QUITE A BIT AND THEY WERE NOT ABLE TO GAUGE HOW MUCH WAS ACTUALLY ADMINISTERED. THE PATIENT REPORTED SOME PSYCHOTIC SYMPTOMS IN BETWEEN INJECTION TIME FRAMES AND HAD TO BE SUPPLEMENTED WITH ORAL ANTIPSYCHOTICS UNTIL THE NEXT INJECTION WAS DUE. NO ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED.

    Patient problems: Unspecified Mental, Emotional or Behavioral Problem

    MAUDE report 12819940 ↗
  • MalfunctionNov 4, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT THE HUB IS CRACKING. THIS OCCURRED DURING DIRECT PATIENT CARE WHILE PREPARING AND PREPPING AN ANTIPSYCHOTIC INJECTION WHICH CAUSED A LEAK OF MEDICATION FROM THE CRACK. THERE WAS NOT A DELAY AS THEY HAD OTHER LOT NUMBERS OF NEEDLES ON HAND.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12752104 ↗
  • MalfunctionNov 4, 2021Crack; Crack

    THE CUSTOMER REPORTED THAT THE HUB IS CRACKING. THIS OCCURRED APPROXIMATELY 8-10 TIMES IN THEIR OFFICE WHILE TRYING TO INVESTIGATE THE POTENTIAL ISSUE; THEY WERE TRYING TO MAKE SURE THE NEEDLE WAS CONNECTED TO THE HUB SECURELY AND LIGHTLY TIGHTENING TO THE SYRINGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12751955 ↗

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.