McKesson 102-SN310C31516PRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20612479187942), received between Apr 14, 2024 and Jul 8, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

8 other recalls cover devices cleared under the same FDA submission (K151949, K993017); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER CLAIMS THAT THE CAPS ARE NOT STAYING ON THE SYRINGE IN THE PACKAGE. ADDITIONALLY, THE CUSTOMER FURTHER EXPLAINED THAT THE NEEDLE COVER ISN'T STAYING ON AND WERE POKING THROUGH THE BAG. A STAFF MEMBER GOT POKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19687259 ↗
• MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER CLAIMS THAT THEY USED THIS NEEDLES TO FEW CLIENTS, HOWEVER, IT CAUSES REDNESS AND ALLERGIC-LIKE REACTION AT THE INJECTED SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639992 ↗
• MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER CLAIMS THAT THE PRODUCT IS LEAKING WHEN IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639985 ↗
• MalfunctionJun 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN SYRINGE IS LEAKING WHEN IN USE. 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 19593215 ↗
• MalfunctionJun 18, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT THE PLUNGER WOULD GET STUCK AND NOT RELEASE BOTOX DURING DRAWING UP AND INJECTING. THIS RESULTED IN LOSS OF PRODUCT. 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 19559295 ↗
• MalfunctionJun 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE NEEDLES ARE NOT SHARP ENOUGH TO PENETRATE THE SKIN EASILY, RESULTING IN PATIENTS EXPERIENCING PAIN (WHICH IS TYPICALLY NOT THE CASE), AND IN TWO INSTANCES, THE PATIENTS DEVELOPED BRUISES.

  Patient problems: Easy Bruising

  MAUDE report 19465564 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DRIPPING OF FLUID WHEN THE SYRINGE IS TRANSFERRED FROM ONE INJECTION POINT TO THE NEXT (COSMETIC INJECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102925 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT WHEN USING AN INSULIN SYRINGE (0.3ML 31GX5/16 "), THE PROTECTIVE CAP WAS FOUND TO COME OFF EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102897 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT CLIENT SAYS THE PLUNGER IS DIFFICULT TO PUSH IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102886 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT SYRINGE PLUNGER BROKEN/DEFECTIVE. NEEDLE WAS ABLE TO PIERCE THE SKIN BUT WAS UNABLE TO DISTRIBUTE THE MEDICATION INTO THE PATIENT'S SKIN, THE MEDICATION RAN DOWN THE PATIENT'S FACE AND THERE APPEARED TO BE A BLOCKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102862 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151949, K993017. One submission often covers many models, so check the product and lot details in each record.

• Z-0119-2019 · Sep 4, 2018 · Terminated
  McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
• Z-3202-2018 · Aug 24, 2018 · Terminated
  Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly b
• Z-0574-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21
• Z-0573-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6999-21
• Z-0569-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to b
• Z-0571-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6997-21
• Z-0572-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21
• Z-0570-2010 · Oct 27, 2009 · Terminated
  AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21