McKesson 16-SN3C201Recalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe/NDL, LL, 3cc · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479207063), received between May 8, 2024 and Sep 9, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- Device Contaminated During Manufacture or Shipping1
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
VACCINE DOSES DRAWN UP IN THESE SYRINGES AND APPEAR TO HAVE FOREIGN BODY DEBRIS INSIDE. THE APPEARANCE IS NOT CONSISTENT WITH NORMAL VACCINE PRECIPITATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166823 ↗MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMS THAT THE PLUNGER WAS BROKEN WHEN DRAWING UP THE MEDICATION AND IT WOULDN'T WORK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19592076 ↗MalfunctionMay 8, 2024Crack; Leak/Splash; Crack; 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 19266359 ↗
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
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- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
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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