McKesson 16-S10CRecalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe, LL 10cc · Class 2
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10612479206882), received between Oct 28, 2022 and May 28, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 Information10
- Break6
- Device Contaminated During Manufacture or Shipping1
- Leak/Splash1
- Wrong Label1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Break; Break
THE CUSTOMER REPORTED THAT SEVERAL SYRINGES BROKE OFF AT THE HUB. BASED ON THE PHOTOS PROVIDED, THE BREAKAGE OCCURRED AT THE HUB, CAUSING THE CONTENTS OF THE SYRINGES TO LEAK. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22094143 ↗MalfunctionJul 1, 2024Break; Break
THE CUSTOMER CLAIMS THAT THE SYRINGE BROKEN IN THE DOCTOR'S HAND, THE PHOTO PROVIDES SHOWN THAT THE FINGER GRIP OF THE SYRINGE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19641441 ↗MalfunctionJul 1, 2024Break; Break
THE CUSTOMER CLAIMS THAT THE FLANGE ON EITHER SIDE OF THE SYRINGE BROKE OFF EACH TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19641398 ↗MalfunctionJun 24, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THEY ATTEMPTED TO FILL THE SYRINGE WITH MEDICATION, THERE APPEARED TO BE SOME BLACK-LIKE PLASTIC OR PARTICLE IN THE SYRINGE. 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 19600330 ↗MalfunctionJun 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
WHEN PUSHING THE PLUNGER DOWN, THE PLASTIC SIDE FLANGES HAVE BROKEN OFF, LEAVING SHARP EDGES. THIS HAPPENED RIGHT IN THE MIDDLE OF AN INJECTION ON A COUPLE OF PATIENTS, AND A DOCTOR CUT HIS HAND ON ONE OCCASION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19465566 ↗MalfunctionJun 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
WHEN PUSHING THE PLUNGER DOWN, THE PLASTIC SIDE FLANGES HAVE BROKEN OFF, LEAVING SHARP EDGES. THIS HAPPENED RIGHT IN THE MIDDLE OF AN INJECTION ON A COUPLE OF PATIENTS, AND A DOCTOR CUT HIS HAND ON ONE OCCASION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19465565 ↗MalfunctionMay 20, 2024Break; Break
THE PLUNGER WAS BREAKING OFF WHEN THEY WERE BEING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19349173 ↗MalfunctionMay 20, 2024Break; Break
WITH LITTLE TO NO PRESSURE APPLIED, THE PLASTIC WINGS SHATTER AS THE PHYSICIAN WAS PUSHING THE PLUNGER IN, CUTTING HIMSELF THROUGH HIS GLOVES IN THE PROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19349035 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
THE CUSTOMER HAD MULTIPLE SYRINGES CRACK DOWN THE SIDE WHILE FLUSHING IVS, IT WAS NOT EVEN A FORCEFUL INJECTION, IT SPRAYS THE SYRINGE CONTENT ALL OVER THE CLINICAL PRACTITIONER AND THE PATIENTS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266499 ↗MalfunctionMay 8, 2024Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD A FEW SYRINGES BREAK OFF AT THE HUB.NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THESE REPORTED ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266466 ↗MalfunctionMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE NUMBERS AND LINES ON THE SYRINGES ARE RUBBED OFF/FADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244511 ↗MalfunctionMay 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
PER CUSTOMER: SOME OF THE SYRINGES HAVE BLACK FLOATING MATERIAL IN THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244505 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT WHEN THE MEDICATION IS PUSHED INTO THE SYRINGE , THE SYRINGE RUPTURES AND THE SIDE OF THE SYRINGE CRACKS OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102935 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE BARREL BROKE AND LIQUID LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102921 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE BARREL BROKE AND DRUG LEAKAGE WHEN USING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102911 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE PLUNGER SEEMS A LITTLE SMALL, RESISTANCE IS SMALL, LEAKAGE OCCURS WHEN PRESSURE IS APPLIED, AND IT IS DIFFICULT TO INJECT 1ML OF LIDOCAINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102902 ↗MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT SYRINGE (10ML LL) CONTAINS HAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102885 ↗MalfunctionApr 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTS THAT FOREIGN MATTER IN THE INTERNAL CAVITY(BLACK FOREIGN MATTER FOUND DURING USE AFTER SYRINGE ASPIRATION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102793 ↗MalfunctionOct 28, 2022Wrong Label
THE OUTSIDE OF THE PACKAGE SAYS "SYRINGE 10CC" BUT WHEN YOU FLIP IT OVER AND REALLY LOOK AT THE GRADUATION LINES THAT ARE ON THE SYRINGE GO TO 12CC/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15690330 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.