McKesson 16-SN3C2558Recalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe/NDL, LL, 3cc · Class 2
Data updated Oct 18, 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 10612479207247), received between May 8, 2024 and Jun 28, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Material Integrity Problem1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMS THAT THE NEEDLES ARE POKING THROUGH CAPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639991 ↗MalfunctionJun 21, 2024Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent
IT WAS REPORTED BY THE CUSTOMER THAT A USED NEEDLE PENETRATED THE CAP. 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 19586697 ↗MalfunctionMay 8, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE CAPS ARE SLIPPING OFF OF THE SYRINGE, IN SOME CASES BEFORE THE SYRINGE IS EVEN PULLED OUT OF THE PACKAGE. THEY HAD 2 NEEDLE STICKS IN THE PAST 2 DAYS BECAUSE OF THIS
Patient problems: Needle Stick/Puncture
MAUDE report 19266486 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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