McKesson 16-SN10C201Recalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe/NDL, LL, 3cc · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10612479207032), received between May 8, 2024 and Sep 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2024Break; Leak/Splash; Break; Leak/Splash
THE CUSTOMER CLAIMS THAT THE FLANGES WERE BREAKING. ALSO NOTED THE PLUNGER BECOMES LOOSE AND LOSSES PRESSURE IF USED MORE THAN 2 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166839 ↗MalfunctionMay 8, 2024Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT ON 3 TO 4 OCCASIONS, THE SYRINGE CRACKED DURING USE PREVENTING ADMINISTRATION OF THE LIDOCAINE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266487 ↗
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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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