McKesson 16-S1CRecalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe, LL 1cc · 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 10612479217284), received between May 8, 2024 and Jun 28, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Insufficient Device Problem Information1
- Leak/Splash1
- Partial Blockage1
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.
MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER CLAIMS THAT THE SYRINGE PLUNGER IS GETTING STUCK IN THE SYRINGE BODY WHILE THEY ARE DOING BOTOX INJECTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639995 ↗MalfunctionJun 27, 2024Partial Blockage; Partial Blockage
IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE PLUNGER IS GETTING STUCK IN THE SYRINGE BODY WHILE THEY ARE DOING INJECTIONS. 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 19624168 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT SEVERAL SYRINGES FROM A BOX WERE FLIMSY AND THAT BOTOX LEAKED FROM THE NEEDLE BEFORE THE INJECTIONS COULD OCCUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266497 ↗MalfunctionMay 8, 2024Break; Break
SMALL CRACKS ARE FOUND ON THE CLEAR PORTION OF SEVERAL 1 CC SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266489 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.