McKesson 16-S5CRecalls & reported problems
Mckesson Medical-Surgical Inc. · Syringe, LL 5cc · Class 2
Quick summary
This McKesson 5cc Luer-lock syringe is used for injecting medications. The 34 reports describe syringes cracking, splitting or breaking apart during injections, sometimes leaking medicine or blood out the sides or from the plunger end, along with a few leaking or loose tip connections. No deaths or injuries are reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10612479207001), received between Apr 9, 2024 and Mar 4, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (15 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
- Leak/Splash15
- Break12
- Crack7
- Compatibility Problem3
- Insufficient Device Problem Information2
- Loose or Intermittent Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Crack; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT SYRINGES ARE CRACKED ON THE SIDES AND THE MEDICINE IS COMING THROUGH THE SIDES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506160 ↗MalfunctionJan 14, 2026Crack; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT WHEN INJECTING A PATIENT, THE SYRINGE BROKE BY SPLITTING LONGITUDINALLY AND MEDICATION SPILLED TO THE FLOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072748 ↗MalfunctionDec 25, 2025Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT FLUORESCEIN DYE LEAKED FROM THE SYRINGE DURING USE, SPECIFICALLY FROM THE PLUNGER SIDE. 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 23892267 ↗MalfunctionDec 11, 2025Crack; Leak/Splash; Crack; Leak/Splash
THE CUSTOMER REPORTED THAT THE SYRINGE CRACKED DURING AN INJECTION AND LEAKED. 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 23775520 ↗MalfunctionNov 19, 2025Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT THE SYRINGES ARE CRACKING WHILE A PROVIDER WAS ADMINISTERING AN INJECTION TO PATIENTS. 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 23593610 ↗MalfunctionNov 14, 2025Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT THEY WERE HAVING DIFFICULTY WITH THE SYRINGE. THE LUER LOCK IS DEFECTIVE AND SPRAYING OUT OF THE TIP OF THE SYRINGE DURING AN INJECTION. 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 23552186 ↗MalfunctionNov 13, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT SYRINGES WERE CRACKING AND FLUID AND BLOOD WERE LEAKING. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THESE PRODUCT ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542894 ↗MalfunctionFeb 18, 2025Crack; Crack
IT WAS REPORTED BY THE CUSTOMER THAT DURING THE ADMINISTRATION OF A STEROID TO THE PATIENT, THE SYRINGE CRACKED AND BURST. HOWEVER, NO MEDICATION WAS INJECTED. NO INFORMATION REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21395447 ↗MalfunctionJul 1, 2024Break; Break
THE CUSTOMER CLAIMS THAT THE BASE OF THE SYRINGE BY THE PLUNGER IS EITHER CRACKED IN HALF OR BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19641344 ↗MalfunctionJun 28, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE COMES OFF (POPS OFF) OF THE SYRINGE AFTER INSERTING IT INTO THE SKIN AND TRYING TO INJECT THE MEDICATION. 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 19632112 ↗MalfunctionJun 13, 2024Break; Leak/Splash; Break; Leak/Splash
IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE FLANGES ON BOTH SIDES OF THE SYRINGE BROKE OFF DURING ADMINISTRATION. IT WAS LATER COMMUNICATED THAT THIS MALFUNCTION RESULTED IN MEDICATION 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 19527628 ↗MalfunctionMay 20, 2024Break; Break
THE SYRINGES ARE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19349076 ↗MalfunctionMay 8, 2024Break; Break
THE SYRINGE USED TO INJECT KENALOG STEROID WITH A 18G NEEDLE. WHEN DEPRESSING THE PLUNGER THE FINGER GRIPS EDGE BROKE/SNAPPED CLOSE TO SEAM AND CUT DOCTORS FINGERS. CAUSED HIM TO BLEED A LOT. THIS HAPPENED TWICE WITH THE SAME DOCTOR ON DIFFERENT DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266544 ↗MalfunctionMay 8, 2024Break; Break
THE SYRINGE PLUNGERS ARE BRITTLE AND BREAKING DURING DOCTOR USING IT FOR SPINAL INJECTIONS. (SEE PHOTO).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266543 ↗MalfunctionMay 8, 2024Break; Break
THE MEDICAL DOCTOR INDICATES THAT THE SYRINGES ARE RUPTURING WHEN PUSHING MEDICATIONS THROUGH THEM. THE SIDES OF SYRINGE ARE BUSTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266536 ↗MalfunctionMay 8, 2024Break; Break
THE SYRINGES ARE BREAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266506 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
ON (B)(6) 2024, THE ISSUE WAS CONFIRMED WITH THE CUSTOMER THAT THE PLUNGER SEAL APPEARED TO BE VERY LOSE AND COULD EVEN SPIN FREELY WITHIN THE SYRINGE. WHEN DRAWING SAMPLES, AIR WAS ENTERING FROM THE BACK SIDE OF THE SEAL AND WOULD NOT ALLOW THE CUSTOMER TO DRAW THE CORRECT ML NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266503 ↗MalfunctionMay 8, 2024Break; Break
SEVERAL OF THE WINGS ON THE BARREL OF THE SYRINGE ARE BREAKING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266502 ↗MalfunctionMay 8, 2024Break; Break
CUSTOMER STATED THAT THE FINGER FLANGE ON THE SYRINGE KEPT BREAKING FOR HER AND SOME SYRINGES ALREADY HAD THAT PART BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266501 ↗MalfunctionMay 8, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
THE PIN SEAT CONNECTION IS LOOSE, AND THE PIN SEAT HAS FALLEN OFF DURING USE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266438 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGES ARE CRACKING WHEN INJECTING CORTISONE. IT IS SUSPECTED THAT THE CRACKING RESULTED IN LEAKAGE. HOWEVER, THIS COULD NOT BE CONFIRMED WITH THE CUSTOMER. 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 19266428 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT DURING AN INJECTION, FLUID BEGAN LEAKING OUT. IT WAS DISCOVERED THAT THE SYRINGE HAD A CRACK ON THE SIDE. A NEW SYRINGE HAD TO BE DRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266427 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT THE SYRINGE CRACKED ALONG THE BARREL DURING AN INJECTION OF A VISCOUS MEDICATION INTO THE JOINT CAUSING THE MEDICATION TO LEAK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266419 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
WE HAVE HAD 3 SYRINGES BREAK WHILE DOCTOR WAS INJECTING 3 DIFFERENT PATIENTS. THE "BARREL FLANGE" BUSTED MAKING A HUGE SNAPPING NOISE DURING THE INJECTIONS AND PIECES WENT FLYING EVERYWHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266409 ↗MalfunctionMay 8, 2024Break; Break
THE TABS ON THE SYRINGE THAT YOU HOLD ON TO WHILE PUSHING ON THE PLUNGER HAVE BROKEN OFF ON SEVERAL SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266405 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.