Magellan 8881833215 (UDI 10884521005792)Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Hypodermic Safety Needle · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521005792), received between Oct 31, 2019 and Sep 20, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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
- Crack3
- Fluid/Blood Leak3
- Break2
- Fail-Safe Problem2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient3
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE NEEDLE CAME LOOSE FROM THE SYRINGE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE NEEDLE WAS COMPLETELY DETACHED FROM THE HUB OF THE SYRINGE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20267575 ↗MalfunctionJul 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT WHILE PULLING UP MEDICINE THE MEDICINE SHOT OUT FROM THE SIDE OF THE SYRINGE ONTO PATIENT'S ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19649731 ↗MalfunctionApr 13, 2023Fail-Safe Problem; Fail-Safe Problem
CUSTOMER REPORTS: WHEN THE NURSE WAS ADMINISTERING IV HALDOL TO A PATIENT, THE SAFETY FOR THE NEEDLE WAS ENGAGED HOWEVER WHEN SHE WENT TO DISPOSE OF THE NEEDLE THE SAFETY MALFUNCTIONED AND THE NEEDLE POKED THROUGH HER GLOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16732971 ↗MalfunctionFeb 18, 2022Break; Break
THE CUSTOMER REPORTED THAT THE PACKAGE WAS OPENED AND THE NEEDLE END WAS FOUND BROKEN APART. THE SECOND PACKAGE OPENED HAD THE SAME FINDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13560675 ↗MalfunctionAug 11, 2021Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THE NEEDLE IS PUNCTURING THE PLASTIC. ADDITIONAL INFORMATION RECEIVED STATED THE CUSTOMER IS ONLY AWARE OF ONE INCIDENT WHERE THE NEEDLE WENT THROUGH THE SHIELD. THIS OCCURRED WHEN THE SAFETY SHIELD WAS ACTIVATED AFTER PATIENT USE. NO INJURY OCCURRED TO A PATIENT OR TO STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12307470 ↗MalfunctionJul 20, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE MEDICATION WAS SPILLING OUT AT THE SIDE OF THE SYRINGE, NEAR THE TOP OF THE SYRINGE ON THE END, WHERE THE PLUNGER INSERTS. THE CUSTOMER BELIEVES, IT MUST HAVE BEEN NEAR THAT END BECAUSE HE WAS ABLE TO DRAW UP THE MEDICATION FINE, WITH NO APPARENT PROBLEMS OR CRACKS. THE MEDICATION SHOT OUT FROM THE SIDE OF THE SYRINGE. THERE WERE TWO STREAMS FROM THE SAME GENERAL LOCATIONS, WHICH IMPLIES A CRACK OF SOME SORT. THE PATIENT WAS ADMINISTERED ATIVAN 2 MG WITH HALDOL 10 MG (A TOTAL OF 3 ML). THE PATIENT DID NOT APPEAR TO GET ANY OF THE MEDICATION THAT WAS ADMINISTERED, AND THE STAFF STOPPED INJECTING ABOUT HALFWAY THROUGH THE SYRINGE BEING EMPTIED. THE PATIENT APPEARED TO SUFFER NO CONSEQUENCES OTHER THAN AN EXTRA POKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10294991 ↗MalfunctionFeb 20, 2020Crack; Crack
THE CUSTOMER REPORTED THAT THE SYRINGES WERE CRACKED FROM THE BOX.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9735265 ↗MalfunctionFeb 10, 2020Break; Break
THE CUSTOMER REPORTED THAT THE REGISTERED NURSE (RN) OPENED A SYRINGE TO PREPARE MEDICATION AND THE SYRINGE WAS BROKEN AT THE LUER TIP WHERE THE NEEDLE ATTACHES.
Patient problems: No Patient Involvement
MAUDE report 9687401 ↗MalfunctionOct 31, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THERE ARE SYRINGES THAT WERE CRACKED. THEY DIDN¿T NOTICE UNTIL THEY WERE GIVING A ROCEPHIN INJECTION AND THE MEDICATION SHOT OUT OF THE SYRINGE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN A LEAD MEDICAL ASSISTANT (MA) WAS GIVING A PATIENT A ROCEPHIN INJECTION AND WHILE SHE WAS PUSHING THE MEDICATION, SHE NOTICED THE SIDE OF THE SYRINGE WAS CRACKED AND THE MEDICATION SHOT OUT THE SIDE. SHE STOPPED GIVING THE INJECTION AND LET THE PATIENT KNOW WHAT HAPPENED. THERE WAS NO PATIENT OR CAREGIVER INJURY OR EXPOSURE. SHE INFORMED THE PROVIDER AND HE WANTED THE PATIENT TO GET ANOTHER INJECTION. SHE MIXED AND DREW UP A NEW DOSE OF ROCEPHIN USING A NEW SYRINGE AND GAVE THE PATIENT THE INJECTION WITHOUT ANY COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9262993 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.