McKesson 16-N18105Recalls & reported problems
Mckesson Medical-Surgical Inc. · Needle, Hypodermic TW, 18GX1 1/2 · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10612479206554), received between May 8, 2024 and Nov 22, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem5
- Break1
- Difficult to Open or Remove Packaging Material1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Foreign Body In Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTS THAT WHEN A NEEDLE PIERCES A VIAL'S RUBBER STOPPER, IT SLICES OFF SMALL BITS OF RUBBER (CORING ISSUE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20756812 ↗MalfunctionOct 31, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HYPODERMIC NEEDLES CAN PIERCE VIAL STOPPERS, POTENTIALLY CAUSING RUBBER DEBRIS TO BE DRAWN INTO SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20576695 ↗MalfunctionOct 31, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE NEEDLES HAVE A CORING ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20576679 ↗MalfunctionOct 31, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HYPODERMIC NEEDLES CAN PIERCE VIAL STOPPERS, POTENTIALLY CAUSING RUBBER DEBRIS TO BE DRAWN INTO SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20576654 ↗MalfunctionSep 27, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE NEEDLE PLUNGER IS DEFECTIVE WHERE BLACK CHUNKS END UP IN THE VIAL WHEN DRAWING UP MEDICATION. IT HAPPENS ABOUT 50% OF THE TIME AND WE HAVE TESTED IT ON MULTIPLE MEDICATIONS/VIALS?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320704 ↗MalfunctionSep 27, 2024Fracture; Fracture
THE CUSTOMER CLAIMS THAT THE NEEDLES ARE BREAKING IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20320703 ↗MalfunctionSep 16, 2024Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES WERE BREAKING IN THE PATIENT. IT WAS COMMUNICATED THAT THE ISSUE OCCURRED ON THREE OCCASIONS. 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 20224962 ↗MalfunctionMay 8, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
THE CUSTOMER STATED THAT OPENING THE PRODUCT HAVE BEEN DIFFICULT, IT CAUSED HER TO DROP THE ITEMS ONTO A NON STERILE FIELD YIELDING THEM UNUSABLE. AFTER FOLLOWING UP WITH CUSTOMER, IT WAS CONFIRMED THAT THE PACKAGING DOES NOT PEEL APART CORRECTLY TO KEEP THE ITEM/FIELD STERILE. THERE ARE 2 NEEDLES OUT OF 5 NEEDLES EXPERIENCED NOT PEEL APART CORRECTLY ISSUE LAST WEEK ALONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266035 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.