Magellan 8881833310 (UDI 10884521005815)Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Hypodermic Safety Needle · Class 2
All models of Magellan (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521005815), received between Jul 15, 2019 and Aug 20, 2021 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak9
- Break2
- Crack2
- Decrease in Suction1
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
- Fail-Safe Problem1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement3
- Needle Stick/Puncture1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT ONE (1) MODERNA (LOT#026A21A) VACCINE DOSE WAS WASTED AFTER NURSING STAFF REPORTED THAT ALMOST ALL OF THE DOSE LEAKED ON THE SIDES OF THE SYRINGE WHERE THE NEEDLE IS ATTACHED TO SYRINGE ITSELF. THE SYRINGE HAD TO BE WASTED AS VACCINE DID NOT PROVIDE FULL 0.5 ML DOSE DUE TO LEAKAGE. THE CUSTOMER OBTAINED THE ITEM FROM MCKESSON AS THEY SUPPORT US GOVERNMENT COVID-19 VACCINATION PROGRAM.
Patient problems: Insufficient Information
MAUDE report 12351098 ↗MalfunctionAug 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE VACCINE DOSE WAS WASTED AFTER THE NURSING STAFF REPORTED THAT ALMOST ALL OF THE DOSE LEAKED INTO THE SYRINGE CAP DURING THE HANDLING OF THE VACCINE. THE CUSTOMER OBTAINS THE ITEM FROM MCKESSON AS THEY SUPPORT US GOVERNMENT COVID-19 VACCINATION PROGRAM.
Patient problems: Insufficient Information
MAUDE report 12351090 ↗MalfunctionAug 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT A DOSE OF COVID-19 VACCINE WAS WASTED DUE TO THE LEAK ON THE SIDE OF THE SYRINGE.
Patient problems: Insufficient Information
MAUDE report 12348622 ↗MalfunctionAug 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT A DOSE OF COVID-19 VACCINE WAS WASTED DUE TO THE LEAK ON THE SIDE OF THE SYRINGE.
Patient problems: Insufficient Information
MAUDE report 12348284 ↗InjuryJun 11, 2021Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THEY HAD AN EMPLOYEE EXPOSURE WITH A NEEDLE STICK. THE NURSE WAS GIVING AN AGITATED PATIENT AN IM INJECTION. WHEN SHE WENT TO ENGAGE THE SAFETY LOCK ON THE SYRINGE, THE NEEDLE FLEW OFF THE SYRINGE AND INTO THE BED. THE NURSING ASSISTANT TRIED TO REPOSITION THE PATIENT SO HE WOULDN¿T GET STUCK WITH THE NEEDLE AND ENDED UP GETTING STUCK HERSELF. THEY ARE NOT SURE IF THERE IS AN ISSUE WITH THE LOT OR ANYTHING RELATED TO THE PRODUCT ITSELF. IT IS POSSIBLE THAT THE NURSE USED A RED BLUNT TIP TO DRAW UP THE MEDICATION AND THEN SCREWED THE 23G NEEDLE BACK ON FOR INJECTION. IF SO, THE NEEDLE MAY NOT HAVE BEEN SCREWED ON TIGHT ENOUGH, WHICH MIGHT BE THE REASON IT CAME OFF OF THE SYRINGE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON JUNE 09, 2021 STATED THAT THE ENTIRE NEEDLE LUER HUB ASSEMBLY DETACHED FROM THE SYRINGE BARREL. THE NURSE HAD USED HER THUMB TO ACTIVATE THE SAFETY SHIELD. SHE DID NOT USE A RED BLUNT TIP, SHE DREW UP THE MEDICATION WITH THE 23G NEEDLE ITSELF. THE CUSTOMER FURTHER STATED THAT THEY CANNOT SHARE ANY INFORMATION REGARDING ANY MEDICAL INTERVENTION, TESTING, OR THE CURRENT STATUS OF THE NURSING ASSISTANT WITHOUT THE CONSENT OF THE INVO
Patient problems: Needle Stick/Puncture
MAUDE report 11982163 ↗MalfunctionApr 19, 2021Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: ON (B)(6) 2021, ONE (1) MODERNA (LOT#044A21A) VACCINE DOSE WAS WASTED AFTER NURSING STAFF REPORTED THAT ALMOST ALL OF THE DOSE LEAKED INTO THE SYRINGE CAP DURING THE HANDLING OF THE VACCINE.
Patient problems: Insufficient Information
MAUDE report 11685596 ↗MalfunctionApr 16, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE BARREL IS CRACKED; WHEN THEY ARE DRAWING/LOADING THE MEDICATION, THE MEDICINE SPILLS FROM THE CRACK IN THE BARREL. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11679380 ↗MalfunctionApr 2, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE NURSING STAFF REPORTED THAT ONE MODERNA VACCINE DOSE, LOT NUMBER 026A21A, LEAKED ON THE SIDES OF THE SYRINGE WHERE THE NEEDLE IS ATTACHED TO THE SYRINGE ITSELF AND THE VACCINE DID NOT PROVIDE THE FULL 0.5 ML DOSE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11610556 ↗MalfunctionFeb 25, 2021Decrease in Suction; Decrease in Suction
THE CUSTOMER REPORTED THEY ARE NOT GETTING SUFFICIENT SUCTION EVEN WITH THE HUB OF THE NEEDLE BEING TIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11378983 ↗MalfunctionJul 29, 2020Break; Break
THE CUSTOMER REPORTED THAT WHEN THE NURSE OPENED THE PACKAGE FOR SYRINGE PREPARATION, SHE NOTED THAT THE BASE OF THE NEEDLE WAS BROKEN OFF INSIDE THE SYRINGE. THE ISSUE WAS NOTICED BEFORE USE.
Patient problems: No Patient Involvement
MAUDE report 10338464 ↗MalfunctionMay 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHILE GIVING THE INJECTION, THE MEDICATION SPRAYS OUT OF THE SIDE OF THE SYRINGE WHERE THE NEEDLE AND THE SYRINGE MEET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10072872 ↗MalfunctionMay 18, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NURSE WAS DRAWING UP MEDICATION INTO THE SYRINGE AND NOTICED THAT THE SIDE OF THE SYRINGE WAS CRACKED AND THE MEDICATION WAS LEAKING OUT.
Patient problems: No Patient Involvement
MAUDE report 10067985 ↗MalfunctionMar 12, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE NURSE WAS OPENING THE SYRINGE PACKAGE AND NOTED THAT THE HUB OF THE NEEDLE WAS BROKEN AND DETACHED WHERE IT CONNECTS TO THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9824049 ↗MalfunctionJul 15, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED THAT THERE IS A WHITE RESIDUE ON THE NEEDLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8788772 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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