McKesson 16-N181Recalls & reported problems
Mckesson Medical-Surgical Inc. · Needle, Hypodermic TW, 18GX1 · Class 2
- 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 10612479206523), received between Apr 14, 2024 and Sep 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Contamination /Decontamination Problem1
- Leak/Splash1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER CLAIMS THAT THE NEEDLE IS PULLING THE VIAL CAP INTO THE IV SOLUTION (CORING ISSUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320697 ↗MalfunctionJun 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMS THAT THE ITEM IS DEFECTIVE, IT LOOKS AND FEELS DIFFERENT, LEAVES A HUGE GAP WHEN INSERTED ONTO THE SYRINGE AND CAUSES LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19591782 ↗MalfunctionJun 20, 2024Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
THE CUSTOMER CLAIMS THAT ON APPROXIMATELY 5 OCCASIONS, THE NEEDLE LEFT A HUGE GAG WHEN INSERTED ONTO THE SYRINGE AND CAUSED LEAKAGE. 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 19574022 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT NEEDLE LEAKAGE, WHEN THE NEEDLE IS ASSEMBLED ON THE SYRINGE, THE PROCESS OF MOVING, THE FLUID OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102883 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.