Magellan 8881850215Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
Quick summary
This Magellan hypodermic safety needle has 41 adverse event reports, with no deaths or injuries. The reports mostly describe fluid leaking at the needle-syringe connection, needle breakage, and safety-lock problems, including some needle sticks. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521000087), received between Mar 6, 2018 and Nov 15, 2024 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (29 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak29
- Break9
- Fail-Safe Problem5
- Fail-Safe Did Not Operate4
- Crack3
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Needle Stick/Puncture4
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2024Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED A NEEDLE STICK INJURY DUE TO FAULTY DESIGN CAUSING NEEDLE TIP TO POKE OFF THE CAP AND THE SAFETY LOCK CAN BE UNLOCKED AND RELOCKED. NO FURTHER INFORMATION WAS PROVIDED NOR CAN BE REQUESTED AT THIS TIME.
Patient problems: Needle Stick/Puncture
MAUDE report 20699218 ↗MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATED THAT THE NURSE COULD NOT GET THE DROP AT THE END OF THE SYRINGE BEFORE INJECTING, AT WHICH POINT SHE REALIZED THERE WAS A LEAK AND THAT THE PRODUCT WAS DRIPPING ONTO HER HANDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450160 ↗MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NURSE ATTEMPTED TO ADMINISTER THE DOSE TO AN INDIVIDUAL PATIENT AND FLUID FROM THE SYRINGE LEAKED AT THE CONNECTION POINT BETWEEN THE NEEDLE AND SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20450094 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SUSPENSION COULD NOT BE INJECTED AND LEAKED FROM THE SIDE OF THE LUER LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447616 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PRODUCT COMES OUT NEXT TO THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447140 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN THE PEN WAS BEING ADMINISTERED TO THE PATIENT, POWDER WAS COMING OUT OF THE END SO COULD NOT BE ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20446316 ↗MalfunctionOct 14, 2024Break; Break
THE CUSTOMER REPORTED THAT THE CANNULA IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20441449 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SUSPENSION LEAKS OUT AT THE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440827 ↗MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SUSPENSION LEAKS OUT BETWEEN THE NEEDLE AND SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20440316 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE NEEDLE HUB HAS BROKEN DURING THE INJECTION. IT CRACKS WHEN THE NURSE INSERTS THE NEEDLE AND THE PRODUCT SPREADS EVERYWHERE DURING THE INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392674 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. NEEDLE SHATTERED IN THE THREAD WHEN SCREWED ONTO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392581 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE NEEDLE HAD NOT WORKED, LIQUID WAS GUSHING OUT FROM THE THREAD. THE MEDICINE LEAKED ONTO THE SKIN THROUGH THE THREADS. WHEN HE TRIED TO INJECT, THE NEEDLE HUB BROKE. AFTER ATTACHING THE NEEDLE TO THE SYRINGE HE HEARD A NOISE, HE NOTICED THAT THE PLASTIC SHEATH AROUND THE NEEDLE WAS CRACKED AND THAT PRODUCT WAS FLOWING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392410 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. WHEN THE NEEDLE WAS FITTED AND SCREWED ONTO THE SYRINGE, THE NURSE HEARD A CRACK. AFTER THE DISMANTLE OF THE SYRINGE, THE TIP THAT SCREWS INTO IT HAD BROKEN OFF PART OF ITS COLLAR. THERE WAS LEAKING FROM THE SYRINGE DURING THE INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392106 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE SCREW PITCH IS CRACKED, SO THE SYRINGE IS IMPOSSIBLE TO USE. SOME OF THE MEDICATION LEAKED DOWN. NURSE REPORTED DURING ADMINISTRATION TO OBSERVE A CRACK IN THE NEEDLE SHAFT. THE CRACK OCCURRED AT THE BASE OF THE NEEDLE (HUB) WHEN IT WAS SCREWED INTO THE SYRINGE. WHEN THE NURSE ATTACHED THE NEEDLE, THE SCREW THREAD ON THE SYRINGE BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391792 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. THE SUBSTANCE BURSTS THROUGH THE NEEDLE SHAFT. THE SYRINGE WOULD NOT ATTACH AND THE NEEDLE HUB CONTINUED TO ROTATE IN A VACUUM. THERE IS A CRACK IN THE NEEDLE TIP BETWEEN THE NEEDLE AND THE SCREW THREAD. THE SYRINGE BROKE BETWEEN THE NEEDLE AND THE START OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391721 ↗MalfunctionOct 7, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED IT WAS OBSERVED THAT THE NEEDLE HUB BROKE WHICH RESULTED IN LEAKAGE AT THE LUER CONNECTION. WHEN THE NURSE INSERTED THE NEEDLE, THE NEEDLE HUB BROKE. PHOTO ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391668 ↗MalfunctionMar 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED AN ISSUE REGARDING THE USE OF THE SAFETY NEEDLE AND STATED "AMPULE BAGS/PFS/VIAL LEAKS." THE PRODUCT INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18961997 ↗MalfunctionMar 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED AN ISSUE REGARDING THE USE OF THE SAFETY NEEDLE AND STATED "AMPULE BAGS/PFS/VIAL LEAKS." THE PRODUCT INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909330 ↗MalfunctionMar 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED AN ISSUE REGARDING THE USE OF THE SAFETY NEEDLE AND STATED "AMPULE BAGS/PFS/VIAL LEAKS." THE PRODUCT INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909247 ↗MalfunctionMar 14, 2024Break; Crack; Fluid/Blood Leak; Break; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED A BROKEN NEEDLE ON THE SAFETY NEEDLE. THE PRODUCT INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909151 ↗MalfunctionMar 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED AN ISSUE REGARDING THE USE OF THE SAFETY NEEDLE AND STATED "AMPULE BAGS/PFS/VIAL LEAKS." THE PRODUCT INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909059 ↗MalfunctionDec 19, 2023Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THROUGH MEDWATCH THAT A REGISTERED NURSE (RN) WAS TO ADMINISTER AN INTRAMUSCULAR INJECTION OF METHERGINE. THE RN USED THE SAFETY FEATURE TO CAP THE NEEDLE AND IT DID NOT CLICK. THE RN WAS POKED ON THE LEFT POINTER FINGER BY THE NEEDLE WHEN THE GUIDE DID NOT CLOSE FULLY. THE PATIENT WAS AWARE OF THE RN'S EXPOSURE AND CONSENTED TO LABORATORY BLOOD WORK.
Patient problems: Needle Stick/Puncture
MAUDE report 18355538 ↗MalfunctionNov 10, 2023Fail-Safe Problem; Fail-Safe Problem
CUSTOMER REPORTS: THE MAGELLAN HYPODERMIC SAFETY NEEDLES SECUREMENT DEVICE IS DIFFICULT TO ENGAGE PROPERLY AND WHEN NOT FULLY ENGAGED THE DEVICE APPEARS TO BE ENGAGED YET THE NEEDLE CAN SLIP OUT OF THE DEVICE WHICH COULD LEAD TO UNNECESSARY NEEDLE STICKS. THIS HAPPENED ON THREE DEVICES WITHIN THE ER TODAY UTILIZED TO MEDICATE A PATIENT. NO STAFF WAS INJURED DUE TO THE DEVICE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18115427 ↗MalfunctionSep 15, 2023Crack; Crack
THE CUSTOMER REPORTED THAT ON A COUPLE OF NEEDLES THE TOP PLASTIC CRACKED WHEN THEY WERE TWISTED. THESE WERE ITEMS THAT THEIR SURGERY DEPARTMENT WAS USING SO THEY ARE CONCERNED ABOUT SMALL PIECES GETTING INTO THE WRONG PLACES. ADDITIONAL INFORMATION PROVIDED ON 12SEP2023 CLARIFIED THAT THE HUB CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17760582 ↗MalfunctionAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED SMALL SPILLAGE FROM STEM OF NEEDLE, AS SUCH FULL DOSE NOT ADMINISTRATED. HOWEVER, NEEDLE WAS TIGHTLY SCREWED ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17505164 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.