Magellan 8881833510 (UDI 10884521005839)Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Hypodermic Safety Needle · Class 2
All models of Magellan (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521005839), received between May 14, 2019 and Jun 3, 2021 — classified as 2 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak5
- Break4
- Fail-Safe Problem4
- Detachment of Device or Device Component3
- Incomplete or Inadequate Connection3
- Contamination /Decontamination Problem2
- Crack1
- Fitting Problem1
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions7
- Needle Stick/Puncture2
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2021Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER STATED THAT THE MEDICAL ASSISTANT WAS FOLLOWING THE MANUFACTURER GUIDELINES OF ENGAGING THE SAFETY DEVICE ON THE NEEDLE BY SLIDING THE NEEDLE ON HARD SURFACES. THE CONTAMINATED NEEDLE BENT BACK AND STUCK THE MA ON THE LEFT THUMB. THE NEEDLE SHOULD HAVE CLOSED SAFELY TO PREVENT A CONTAMINATED NEEDLE STICKS AS SHOWN IN THE GUIDELINES.
Patient problems: Needle Stick/Puncture
MAUDE report 11932818 ↗MalfunctionMay 12, 2021Break; Break
THE CUSTOMER REPORTED THE NEEDLE ASSEMBLE BROKE AWAY FROM THE SYRINGE HUB WHILE ADMINISTERING VACCINE TO A PATIENT, CAUSING VACCINE TO BE WASTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11812583 ↗MalfunctionMay 12, 2021Break; Break
THE CUSTOMER REPORTED THE NEEDLE ASSEMBLE BROKE AWAY FROM THE SYRINGE HUB WHILE ADMINISTERING VACCINE TO A PATIENT, CAUSING VACCINE TO BE WASTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11812578 ↗MalfunctionMay 12, 2021Break; Break
THE CUSTOMER REPORTED ON TWO OCCASIONS THE NEEDLE ASSEMBLY BROKE AWAY FROM THE SYRINGE HUB WHILE VACCINE WAS BEING DRAWN UP, CAUSING THE VACCINE TO BE WASTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11812517 ↗MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE VACCINE CAME OUT FROM THE CONNECTOR OF THE SYRINGE AND NEEDLE AND WENT DOWN THE PATIENT'S ARM. THE TWO PARTS WERE TIGHTLY CONNECTED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11740322 ↗MalfunctionApr 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE VACCINATION CAME OUT OF THE CONNECTOR OF THE NEEDLE AND SYRINGE WHEN GIVING A COVID VACCINATION AND IT RAN DOWN THE PATIENT'S ARM. THE CONNECTIONS WERE SECURE AND TIGHT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11740296 ↗MalfunctionApr 27, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED A SYRINGE DETACHED FROM A NEEDLE WHILE ADMINISTERING THE VACCINE. THE VACCINATOR STATES THAT THE NEEDLE WAS ADVANCED INTO THE PATIENT'S ARM, INJECTING THE VACCINE, HOWEVER, AS SHE REMOVED THE NEEDLE THE SYRINGE DETACHED FROM THE NEEDLE CAUSING THE NEEDLE TO REMAIN IN PLACE AND SOME OF THE VACCINE TO EXPEL ONTO THE PATIENTS ARM AND THE VACCINATOR FACE. THE CUSTOMER BELIEVES THAT GREATER THAN 50% OF THE VACCINE WAS RECEIVED. CDC GUIDELINES WERE REVIEWED WITH THE PATIENT CONCERNING THIS SCENARIO. THE PATIENT WAS GIVEN THE OPTION TO RECEIVE AN ADDITIONAL DOSE IN THE OPPOSITE ARM PER THE GUIDELINES. THE PATIENT REFUSED. ADDITIONAL INFORMATION PROVIDED ON 27-APR-2021 STATED THAT THE PATIENT WAS RECEIVING THE COVID19 VACCINE. THE NEEDLE WAS REMOVED MANUALLY BY THE VACCINATOR. THERE WAS NO INJURY OR HARM TO THE VACCINATOR. THERE WAS NO INJURY TO THE PATIENT BESIDES THE NEEDLE REMAINING IN THE PATIENT AFTER THE VACCINATOR TRIED TO INITIALLY REMOVE IT FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11734900 ↗MalfunctionMar 23, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THEY WERE INJECTING SALINE FROM THE SYRINGE INTO THE COVID-19 VACCINE VIAL WHEN THEY NOTICED THE SALINE WAS LEAKING OUT OF THE SYRINGE AND ONTO THE NURSES HAND FROM A CRACK. THERE WAS NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11552011 ↗MalfunctionJan 13, 2021Fitting Problem; Fitting Problem
THE CUSTOMER REPORTED THAT THEY ATTEMPTED TO TIGHTEN THE NEEDLE TIP TO THE SYRINGE BODY. THE NEEDLE TIP WOULDN'T SEAT AND THE LUER LOCK WOULD NOT TIGHTEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11164545 ↗MalfunctionFeb 20, 2020Break; Break
THE CUSTOMER REPORTED THAT PRIOR TO ADMINISTRATION OF A VACCINE, THE PLASTIC TIP OF THE SYRINGE WAS NOTICED TO BE BENT AND DAMAGED. THERE WAS NO INJURY TO THE PATIENT OR STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732845 ↗MalfunctionFeb 12, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THAT THEY NOTICED A FIBER ON THE NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9699385 ↗MalfunctionJan 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THAT THERE WERE FIBERS ON THE NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9595687 ↗InjuryJan 10, 2020Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT AFTER THE NURSE GAVE THE SHOTS TO THE PATIENT, THE SAFETY SHIELD WAS LOCKED IN PLACE. THE NEEDLE WAS STICKING OUT THE SIDE OF THE SHIELD WHICH CAUSED A NEEDLE PUNCTURE TO THE NURSE'S THUMB WHILE THE NEEDLE WAS BEING DISPOSED OF IN THE SHARPS CONTAINER. NEEDLE STICK PROTOCOL WAS FOLLOWED AND THERE WAS NO DUTY RESTRICTIONS FOR THE NURSE AFTER EXPOSURE.
Patient problems: Needle Stick/Puncture
MAUDE report 9575212 ↗MalfunctionDec 12, 2019Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THE NEEDLE'S SAFETY SHIELD WAS ALREADY DEPLOYED IN THE PACKAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9460115 ↗MalfunctionDec 12, 2019Detachment of Device or Device Component; Incomplete or Inadequate Connection; Detachment of Device or Device Component; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED THE TIP WAS NOT ATTACHED PROPERLY AND FELL OFF. ADDITIONAL INFORMATION PROVIDED ON 05-DEC-2019 STATED THAT THE TIP WAS REFERRING TO THE NEEDLE NOT BEING ATTACHED TO THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9460088 ↗MalfunctionDec 12, 2019Detachment of Device or Device Component; Incomplete or Inadequate Connection; Detachment of Device or Device Component; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED THE TIP WAS NOT ATTACHED PROPERLY AND FELL OFF. ADDITIONAL INFORMATION PROVIDED ON 04-DEC-2019 STATED THE TIP WAS REFERRING TO THE NEEDLE NOT BEING ATTACHED TO THE SYRINGE. THE ISSUE WAS NOTICED BEFORE USE AND THERE WAS NO PATIENT/STAFF INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9458243 ↗MalfunctionDec 11, 2019Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED THAT THE NEEDLE WAS IMPROPERLY ATTACHED TO THE LUER OF THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 9450736 ↗MalfunctionDec 9, 2019Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THE STAFF WAS DEMONSTRATING WITH THE SYRINGES AND FOUND A NEEDLE WITH THE SAFETY SHIELD ALREADY DEPLOYED IN THE PACKAGE. THIS ISSUE WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT/STAFF INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9440182 ↗MalfunctionMay 14, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHEN GIVING THE INJECTION, THE VACCINE SHOT OUT OF THE BACK OF THE SYRINGE PAST THE PLUNGER. THE CHILD NEEDED ANOTHER POKE TO RECEIVE THE VACCINE. ADDITIONAL INFORMATION RECEIVED ON 14-MAY-2019 STATED THAT THE CHILD WAS TO GET TETANUS-DIPTHERIA-PERTUSSIS-POLIO- HIB VACCINE IN THAT SYRINGE. FURTHERMORE IT WAS STATED THAT THE CHILD DID NOT RECEIVE ANY VACCINE FROM THE INITIAL SYRINGE AS THE MEDICAL ALL CAME OUT THE PLUNGER END OF THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8609956 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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