Magellan 8881850515Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521145047), received between Nov 1, 2017 and Feb 20, 2024 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 Leak7
- Fail-Safe Problem3
- Fail-Safe Did Not Operate2
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement2
- Exposure to Body Fluids1
- Needle Stick/Puncture1
- No Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2024Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT AN MA HAS HAD CONCERNS WHEN CLOSING THE SAFETY. THEY HAD ONE THAT THE NEEDLE WENT THROUGH THE SAFETY. ALSO, THEY MENTIONED SEVERAL TIMES THAT THE SAFETY CLOSURE WAS FLIMSY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743920 ↗MalfunctionJun 19, 2023Use of Device Problem; Fail-Safe Did Not Operate; Use of Device Problem; Fail-Safe Did Not Operate
CUSTOMER REPORTS: OUR STAFF HAS ENCOUNTERED ISSUES WITH THE MAGELLAN 25G NEEDLE. OUR NURSE HAD A NEEDLE STICK AFTER INJECTING MEDS TO A HIV POSITIVE PATIENT. SHE FOLLOWED THE CORRECT SAFETY TECHNIQUE. HOWEVER, THE NEEDLE BENT OUT WHILE SHE WAS PRESSING THE SAFETY GLIDE. THE NEEDLE IS TOO FLIMSY SO THAT IT CANNOT SUPPORT THE GLIDE. THE INCIDENT WAS ENTERED IN THE CEDARS SINAI SAFE FOR FURTHER INVESTIGATION AND FOR TRACKING PURPOSES IF IT WARRANTS PULLING IT FROM OUR SUPPLIES.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 17159758 ↗MalfunctionMay 26, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
CUSTOMER REPORTS: OUR STAFF HAS ENCOUNTERED ISSUES WITH THE MAGELLAN 25G NEEDLE. OUR NURSE EXPERIENCED A MALFUNCTIONED SAFETY GLIDE THUS SHE HAD TO DISCARD IT WITHOUT A COVER WHICH IS ALSO UNSAFE FOR THE STAFF. THE INCIDENTS WERE ENTERED IN THE CEDARS SINAI SAFE FOR FURTHER INVESTIGATION AND FOR TRACKING PURPOSES IF IT WARRANTS PULLING IT FROM OUR SUPPLIES.. SHE FOLLOWED THE CORRECT SAFETY TECHNIQUE. HOWEVER, THE NEEDLE BENT OUT WHILE SHE WAS PRESSING THE SAFETY GLIDE. THE NEEDLE IS TOO FLIMSY SO THAT IT CANNOT SUPPORT THE GLIDE. THE INCIDENT WAS ENTERED IN THE CEDARS SINAI SAFE FOR FURTHER INVESTIGATION AND FOR TRACKING PURPOSES IF IT WARRANTS PULLING IT FROM OUR SUPPLIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17014281 ↗MalfunctionOct 29, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DOCTOR PACKHAM WAS PERFORMING A BURSITIS INJECTION IN THE PATIENT'S LEFT HIP WITH A 25X1.5" NEEDLE WHEN THE SOLUTION CAME OUT AROUND THE HUB. THEY TRIED A 2ND NEEDLE OF THE SAME PRODUCT AND THE SAME THING HAPPENED. THEY THEN TRIED A 27X1.5" NEEDLE AND IT WAS SUCCESSFUL. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10755868 ↗MalfunctionOct 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER STATES THAT WHEN THE NEEDLE IS ATTACHED TO THE SYRINGE, IT LEAKS THE SOLUTION OUT OF THE CONNECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10750546 ↗MalfunctionSep 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE RADIOLOGISTS AT THE FACILITY REPORTED THAT DURING CONTRAST JOINT INJECTIONS, THE SAFETY NEEDLES HAVE BEEN LEAKING CONTRAST.
Patient problems: No Information
MAUDE report 10520603 ↗MalfunctionDec 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE MEDICATION LEAKS OUT ON TO THE SKIN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN ADMINISTERING THE FLU VACCINE, THE VACCINE LEAKS OUT OF THE HUB. THE CUSTOMER FURTHER STATED THAT THERE WAS NO DAMAGE NOTICED TO THE HUB. THERE WAS NO MEDICATION EXPOSURE TO THE PATIENT OR STAFF. NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9466217 ↗MalfunctionDec 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE MEDICATION LEAKS OUT ON TO THE SKIN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN ADMINISTERING THE FLU VACCINE, THE VACCINE LEAKS OUT OF THE HUB. THE CUSTOMER FURTHER STATED THAT THERE WAS NO DAMAGE NOTICED TO THE HUB. THERE WAS NO MEDICATION EXPOSURE TO THE PATIENT OR STAFF. NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9466192 ↗MalfunctionDec 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE MEDICATION LEAKS OUT ON TO THE SKIN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN ADMINISTERING THE FLU VACCINE, THE VACCINE LEAKS OUT OF THE HUB. THE CUSTOMER FURTHER STATED THAT THERE WAS NO DAMAGE NOTICED TO THE HUB. THERE WAS NO MEDICATION EXPOSURE TO THE PATIENT OR STAFF. NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9466191 ↗MalfunctionDec 9, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE MEDICATION LEAKS OUT INTO THE SKIN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN ADMINISTERING THE FLU VACCINE, THE VACCINE LEAKS OUT OF THE HUB. THE CUSTOMER FURTHER STATED THAT THERE WAS NO DAMAGE NOTICED TO THE HUB. THERE WAS NO MEDICATION EXPOSURE TO THE PATIENT OR STAFF. NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9438943 ↗MalfunctionJun 14, 2018Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THERE WERE THREE MAGELLAN 25 G 1.5" SAFETY NEEDLES FROM THE SAME BOX/LOT THAT DO NOT ALLOW THE SAFETY FEATURE TO ENGAGE SO THAT THE NEEDLE IS COVERED.
Patient problems: No Patient Involvement
MAUDE report 7602950 ↗MalfunctionNov 1, 2017Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE SAFETY SHIELD IS NOT ENGAGING, LEAVING THE NEEDLE EXPOSED.
Patient problems: No Patient Involvement
MAUDE report 6994514 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.