Magellan 8881833558 (UDI 10884521005846)Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Hypodermic Safety Needle · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521005846), received between Nov 1, 2017 and Apr 12, 2024 — classified as 1 injury, 15 malfunctions.
The most frequently reported specific device problem is “Crack” (6 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
- Crack6
- Break4
- Detachment of Device or Device Component3
- Fluid/Blood Leak2
- Disconnection1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient7
- No Patient Involvement6
- Insufficient Information1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2024
THE ISSUE IS THAT THE NEEDLE IS NOT ALWAYS ¿PREATTACHED¿ WELL AND BECOMES DETACHED WHEN TRYING TO DRAW OUT THE MEDICATION FOR USE DURING OUR IONTOPHORESIS TREATMENT, THUS FORCING THE CLINICIAN TO EITHER DUMP IT INTO THE SHARPS CONTAINER AND GET ANOTHER ONE OR TRY TO PUSH THE NEEDLE BACK INTO THE SYRINGE (BY HOLDING ONTO THE NON-SHARP PART OF THE NEEDLE WHERE IT INSERTS INTO THE SYRINGE. THIS IS AN UNSAFE PRACTICE. TWO LOT NUMBERS ARE AFFECTED, 118056 AND S14684. NOT ALL DEVICES IN THESE LOTS EXHIBITED FAILURES. THE FAILURES WERE SPORADIC.
Patient problems: Insufficient Information
MAUDE report 19095775 ↗MalfunctionSep 18, 2020Crack; Crack
THE CUSTOMER REPORTED THAT THE MAGELLAN SYRINGE WAS BROKEN AT THE HUB. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10556916 ↗MalfunctionSep 15, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE NEEDLE WAS NOT FULLY TIGHTENED ON THE SYRINGE AND IT WAS NOT CHECKED BEFORE USING THE SYRINGE/NEEDLE. THE MEDICATION SQUIRTED OUT AROUND THE CONNECTION. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10534618 ↗InjurySep 15, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE NEEDLE WAS NOT FULLY TIGHTENED ON THE SYRINGE AND THE MEDICATION SQUIRTED OUT AROUND THE CONNECTION. THE NEEDLE SHOT OFF THE SYRINGE CAUSING A NEEDLE STICK INJURY.
Patient problems: No Information
MAUDE report 10534240 ↗MalfunctionMar 4, 2020Crack; Crack
THE CUSTOMER REPORTED THAT THERE WAS A CRACK ON THE SYRINGE BARREL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9789282 ↗MalfunctionFeb 27, 2020Crack; Crack
THE CUSTOMER REPORTED THAT THE SYRINGE BARREL WAS CRACKED.
Patient problems: No Patient Involvement
MAUDE report 9763592 ↗MalfunctionFeb 21, 2020Break; Break
THE CUSTOMER REPORTED THAT THE LUER TIP WHERE THE NEEDLE AND SYRINGE CONNECT IS DAMAGED. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9738796 ↗MalfunctionNov 21, 2019Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO THEIR DISTRIBUTOR THAT TWO SYRINGE/NEEDLE COMBOS HUBS WERE CRACKED AND BROKEN OFF FROM THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 9356803 ↗MalfunctionNov 19, 2019Crack; Crack
THE CUSTOMER REPORTED TO THEIR DISTRIBUTOR THAT THE SYRINGE BARREL IS CRACKED.
Patient problems: No Patient Involvement
MAUDE report 9342113 ↗MalfunctionNov 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO THE DISTRIBUTOR THAT THE NEEDLE WAS BROKEN. ACCORDING TO THE PHOTOGRAPH PROVIDED, THE HUB WAS BROKEN/DETACHED FROM THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 9341727 ↗MalfunctionNov 6, 2019Disconnection; Disconnection
THE CUSTOMER REPORTED THAT THE SYRINGES WERE FOUND DETACHED FROM THE LUER INSIDE OF THE PACKAGE BEFORE THE PRODUCT WAS OPENED.
Patient problems: No Patient Involvement
MAUDE report 9285627 ↗MalfunctionNov 6, 2019Crack; Crack
THE CUSTOMER REPORTED THAT THE HUB OF THE NEEDLE WAS CRACKED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THE ISSUE WAS DISCOVERED BEFORE USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9284103 ↗MalfunctionNov 4, 2019Break; Break
THE CUSTOMER REPORTED THAT THEY DISCOVERED A BROKEN NEEDLE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9271950 ↗MalfunctionOct 29, 2019Break; Break
THE CUSTOMER REPORTED THAT THE NEEDLE WAS DEFECTIVE. BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER, THE HUB OF THE NEEDLE IS COMPLETELY CRACKED INTO TWO PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9253882 ↗MalfunctionAug 16, 2019Break; Material Deformation; Break; Material Deformation
THE CUSTOMER REPORTED THE TIP OF THE SYRINGE WAS BROKEN AND MELTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8901272 ↗MalfunctionNov 1, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT DURING VACCINE ADMINISTRATION, THE NEEDLE SEPARATED FROM SYRINGE AND VACCINE RAN DOWN CLIENT'S ARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6993123 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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