McKesson 16-SNT1C2705Recalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe/NDL,TB, 1cc · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10612479207322), received between Dec 23, 2022 and May 8, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
- Material Puncture/Hole1
- Physical Resistance/Sticking1
- Protective Measures Problem1
Patient problems
- Needle Stick/Puncture2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
WHEN OPENING THE PACKAGE, THE NEEDLES WAS NOT ATTACHED TO THE SYRINGE PROPERLY, IT WILL FALL OFF. ONLY SOME OF THEM, BUT NOT ALL OF THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266488 ↗MalfunctionMay 8, 2024Material Puncture/Hole; Material Puncture/Hole
THE NEEDLE WENT THROUGH THE SHEATH WHEN SHE WAS RECAPPING.? THE NEEDLE WAS NOT THROUGH THE SHEATH OR ANY OF THE PACKAGING PRIOR TO USE.
Patient problems: Needle Stick/Puncture
MAUDE report 19266222 ↗MalfunctionJan 18, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Protective Measures Problem
THE NEEDLES FOR LIDOCAINE- I HAD ONE BREAK OFF IN TODAY AND SPRAY US BOTH IN THE PROCESS. I¿VE HAD THIS HAPPEN IN THE PAST WITH THE SAME NEEDLES. THE NEEDLE JUST SLIPS ON IT IS NOT A LUER LOCK. THIS CAUSES ISSUES WITH THE NEEDLE COMING OFF UPON REMOVAL FROM THE SKIN AND STICK INJURIES.
Patient problems: Needle Stick/Puncture; Unspecified Tissue Injury
MAUDE report 16193959 ↗MalfunctionDec 23, 2022Physical Resistance/Sticking
WHEN I UNPACKED THE SYRINGE, THE TOP CAME OFF. I HAD TO HOLD THE NEEDLE PORTION IN PLACE TO TAKE THE SAFETY OFF AND DRAW UP THE SYRINGE. THE MAJOR ISSUE IS WHEN I INSERTED THE NEEDLE TO GIVE THE TB HEPARIN AND AS I PUSHED THE PLUNGER THE SYRINGE WAS COMPLETELY REMOVED FROM THE NEEDLE DUE TO THE SMALL AMOUNT OF PRESSURE OF PUSHING THE PLUNGER. THE HEPARIN WENT EVERYWHERE AND INTO MY LEFT EYE. DUE TO THIS, THE NEEDLE WAS ALSO STUCK AND STILL IN THE PATIENT'S SKIN. I HAD TO PULL IT OUT AND SAFETY CAP IT. THESE SYRINGES ARE IMPOSSIBLE TO USE SAFELY.
Patient problems: Insufficient Information
MAUDE report 16042320 ↗
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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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