McKesson 16-S3CRecalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe, LL 3cc · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10612479206974), received between Dec 13, 2017 and Feb 27, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash5
- Crack1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body Sensation in Eye1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Crack; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT SYRINGES ARE CRACKED ON THE SIDES AND THE MEDICINE IS COMING THROUGH THE SIDES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24476250 ↗MalfunctionAug 22, 2025Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED RESISTANCE WHEN PULLING THE SYRINGE PLUNGER PAST THE 2.5 ML MARK, DESCRIBING IT AS A "SPEED BUMP" SENSATION. THIS CAUSED LEAKAGE DURING IM VITAMIN DRAWING, RESULTING IN FLUID ON THE PLUNGER AND THE STAFF MEMBER'S HAND. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22871014 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
THE NEEDLE DID NOT LOCK INTO THE SYRINGE. IT KEPT TWISTING AND DID NOT LOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266354 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
IN THE MIDDLE OF INJECTING ROCEPHIN, THE BODY OF THE SYRINGE BURST. THE MEDICATION BLEW OUT OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266347 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
PHYSICIAN WAS ADMINISTERING CONTRAST AND THE PLUNGER JAMMED SQUIRTING CONTRAST IN HIS EYES OUT OF THE BACK END OF THE SYRINGE. NO CRACK WAS NOTED.
Patient problems: Foreign Body Sensation in Eye
MAUDE report 19266314 ↗OtherDec 13, 2017Device Contamination with Chemical or Other Material
WHEN OPENING THE SINGLE USE STERILE 3CC SYRINGE, A HAIR WAS NOTICED INSIDE THE SYRINGE. THIS CLEARLY IS AN UN-STERILE SYRINGE. ON (B)(6) 2017 I WAS PREPARING TO INJECT A SVIS PATIENT. WHEN I WAS GATHERING MY SYRINGES TO PREPARE INJECTION ON PATIENT, I UNWRAPPED THE SINGLE 3CC LUER LOCK TIP STERILE SYRINGE, AND NOTED A HAIR INSIDE THE SYRINGE. THE HAIR IS LONG AND APPARENT, AND CLEARLY THIS SYRINGE WAS NOT PACKED STERILE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7120590 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.