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McKesson 102-SN3C231SRecalls & reported problems

Mckesson Medical-Surgical Inc. · SYRINGE/NDL, SAFETY 3CC 23GX1" · Class 2

Adverse event reports
12
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20612479179053), received between Dec 21, 2018 and Jun 13, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (7 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 5 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Activation Failure7
  • Activation Problem3
  • Detachment of Device or Device Component2
  • Material Too Soft/Flexible2
  • Positioning Failure2

Patient problems

  • No Clinical Signs, Symptoms or Conditions7
  • No Patient Involvement4
  • Needle Stick/Puncture1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 13, 2025Activation Failure; Activation Failure

    THE USER FACILITY REPORTED THAT THE SAFETY WAS NOT ENGAGING AFTER THE INJECTION WAS GIVEN. THEY PUSHED DOWN ON THE COUNTERTOP AS THEY ARE SUPPOSED TO, AND THE SAFETY WOULD NOT LOCK. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAY-2025: THERE WAS NOT AN INJURY THAT OCCURRED DUE TO THE FAULTY SAFETY, THE MEDICAL ASSISTANTS (MA'S) AND THE PROVIDER CAUGHT IT RIGHT AWAY WITH THE FIRST SYRINGE THAT WAS USED. THERE WAS NO INJURY THAT OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22203903 ↗
  • MalfunctionJun 13, 2025Activation Failure; Activation Failure

    THE USER FACILITY REPORTED THAT THE SAFETY WAS NOT ENGAGING AFTER THE INJECTION WAS GIVEN. THEY PUSHED DOWN ON THE COUNTERTOP AS THEY ARE SUPPOSED TO, AND THE SAFETY WOULD NOT LOCK. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAY-2025: THERE WAS NOT AN INJURY THAT OCCURRED DUE TO THE FAULTY SAFETY, THE MEDICAL ASSISTANTS (MA'S) AND THE PROVIDER CAUGHT IT RIGHT AWAY WITH THE FIRST SYRINGE THAT WAS USED. THERE WAS NO INJURY THAT OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22203888 ↗
  • MalfunctionJun 13, 2025Activation Failure; Activation Failure

    THE USER FACILITY REPORTED THAT THE SAFETY WAS NOT ENGAGING AFTER THE INJECTION WAS GIVEN. THEY PUSHED DOWN ON THE COUNTERTOP AS THEY ARE SUPPOSED TO, AND THE SAFETY WOULD NOT LOCK. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAY-2025: THERE WAS NOT AN INJURY THAT OCCURRED DUE TO THE FAULTY SAFETY, THE MEDICAL ASSISTANTS (MA'S) AND THE PROVIDER CAUGHT IT RIGHT AWAY WITH THE FIRST SYRINGE THAT WAS USED. THERE WAS NO INJURY THAT OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22203876 ↗
  • MalfunctionJun 13, 2025Activation Failure; Activation Failure

    THE USER FACILITY REPORTED THAT THE SAFETY WAS NOT ENGAGING AFTER THE INJECTION WAS GIVEN. THEY PUSHED DOWN ON THE COUNTERTOP AS THEY ARE SUPPOSED TO, AND THE SAFETY WOULD NOT LOCK. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAY-2025: THERE WAS NOT AN INJURY THAT OCCURRED DUE TO THE FAULTY SAFETY, THE MEDICAL ASSISTANTS (MA'S) AND THE PROVIDER CAUGHT IT RIGHT AWAY WITH THE FIRST SYRINGE THAT WAS USED. THERE WAS NO INJURY THAT OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22203869 ↗
  • MalfunctionJun 5, 2025Activation Failure; Activation Failure

    THE USER FACILITY REPORTED THAT THE SAFETY WAS NOT ENGAGING AFTER THE INJECTION WAS GIVEN. THEY PUSHED DOWN ON THE COUNTERTOP AS THEY ARE SUPPOSED TO, AND THE SAFETY WOULD NOT LOCK. NO BLOOD LOSS WAS REPORTED. THERE WAS NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAY-2025: THERE WAS NOT AN INJURY THAT OCCURRED DUE TO THE FAULTY SAFETY, THE MEDICAL ASSISTANTS (MA'S) AND THE PROVIDER CAUGHT IT RIGHT AWAY WITH THE FIRST SYRINGE THAT WAS USED. THERE WAS NO INJURY THAT OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22149072 ↗
  • MalfunctionMay 18, 2021Positioning Failure; Activation Failure; Material Too Soft/Flexible; Positioning Failure; Activation Failure; Material Too Soft/Flexible

    THE USER FACILITY REPORTED THAT THE NURSING STAFF REPORTED THAT THE FOLLOWING MCKESSON NEEDLE WAS TO FLIMSY (THE CAP DID NOT CLICK/LOCK INTO PLACE AFTER THE INJECTION/ADMINISTRATION) AND MAY POSE POTENTIAL SAFETY/INJURY ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON 26APRIL2021: NURSES REPORTED THE NEEDLES WERE FLIMSY MAKING IT DIFFICULT TO CLICK INTO SAFETY TO ACTIVATE. IT HAS BEEN CONFIRMED THAT NO NEEDLE STICKS INCURRED, AMONG THE NURSES, AND THE PATIENTS WAS NOT AFFECTED IN ANY WAY. PATIENTS RECEIVED THEIR MEDICATIONS BEING DELIVERED AS INTENDED FOR EMERGENCY PSYCHIATRIC CARE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11841781 ↗
  • MalfunctionMay 18, 2021Positioning Failure; Activation Failure; Material Too Soft/Flexible; Positioning Failure; Activation Failure; Material Too Soft/Flexible

    THE USER FACILITY REPORTED THAT THE NURSING STAFF REPORTED THAT THE FOLLOWING MCKESSON NEEDLE WAS TO FLIMSY (THE CAP DID NOT CLICK/LOCK INTO PLACE AFTER THE INJECTION/ADMINISTRATION) AND MAY POSE POTENTIAL SAFETY/INJURY ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON 26APRIL2021: NURSES REPORTED THE NEEDLES WERE FLIMSY MAKING IT DIFFICULT TO CLICK INTO SAFETY TO ACTIVATE. IT HAS BEEN CONFIRMED THAT NO NEEDLE STICKS INCURRED, AMONG THE NURSES, AND THE PATIENTS WAS NOT AFFECTED IN ANY WAY. PATIENTS RECEIVED THEIR MEDICATIONS BEING DELIVERED AS INTENDED FOR EMERGENCY PSYCHIATRIC CARE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11841682 ↗
  • MalfunctionDec 27, 2018Activation Problem; Activation Problem

    THE USER FACILITY REPORTED THAT THE SAFETY MECHANISM IS FAULTY AND A NEEDLE STICK OCCURRED AS A RESULT. THE SAFETY MECHANISM DID NOT CATCH. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: DURING THE PATIENT ADMISSION, THE CLIENT BEGAN VOMITING ON THE FLOOR AND AROUND THE TOILET. AN IM PHENERGAN WAS ORDERED. THE PATIENT WAS LAYING ON THE FLOOR, INEBRIATED, RETCHING AND CRYING. A PHENERGAN INJECTION WAS ADMINISTERED, WITH A MCKESSON SAFETY SYRINGE, INTO THE PATIENTS LEFT DELTOID. THE SAFETY MECHANISM WAS MOVED INTO PLACE, AND FELT LIKE IT WAS CLICKED INTO PLACE. A BANDAGE WAS PLACED ON THE PATIENT'S INJECTION SITE, AND COMFORT WAS PROVIDED TO THE CLIENT WHILE HE WAS LYING ON THE FLOOR. WHEN THE BANDAGE, ALCOHOL WRAPPERS, AND THE NEEDLE WAS PICKED UP TO DISPOSE OF, THE SAFETY CAP MOVED BACK OFF OF, AND EXPOSED THE NEEDLE, INADVERTENTLY STICKING THE NURSE IN THE LEFT THUMB. THE ACTUAL PATIENT WAS NOT IMPACTED. THE PROCEDURE OF THE INJECTION WAS COMPLETED AS INTENDED. THE NURSE INVOLVED GOT BLOOD WORK DONE AS PER POLICY. SHE WAS OFFERED THE OPTION OF PROPHYLACTICS AND DECLINED DUE TO THE HISTORY OF THE PATIENT BEING NON-HIGH RISK. PATIENTS' BLOOD WORK WAS ORDERED TO RULE OUT ANY INFECTI

    Patient problems: Needle Stick/Puncture

    MAUDE report 8199348 ↗
  • MalfunctionDec 21, 2018Activation Problem; Activation Problem

    THE USER FACILITY REPORTED THAT THE SYRINGE WITH SAFETY NEEDLE SAFETY MECHANISM IS FAULTY. THE SAFETY MECHANISM DID NOT CATCH. THERE WAS NO PATIENT IMPACT. THERE WAS NO PROCEDURE IMPACT AS THE PRODUCT WAS NOT BEING USED FOR A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: IT WAS REPORTED THAT THE DEVICE WAS EITHER VERY DIFFICULT TO ENGAGE "THEY HAD TO PUSH VERY HARD", OR BECAME DISENGAGED FROM THE SAFETY FEATURE."

    Patient problems: No Patient Involvement

    MAUDE report 8189018 ↗
  • MalfunctionDec 21, 2018Activation Problem; Activation Problem

    THE USER FACILITY REPORTED THAT THE SYRINGE WITH SAFETY NEEDLE SAFETY MECHANISM IS FAULTY. THE SAFETY MECHANISM DID NOT CATCH. THERE WAS NO PATIENT IMPACT. THERE WAS NO PROCEDURE IMPACT AS THE PRODUCT WAS NOT BEING USED FOR A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 12/5/2018: IT WAS REPORTED THAT THE DEVICE WAS EITHER VERY DIFFICULT TO ENGAGE "THEY HAD TO PUSH VERY HARD", OR BECAME DISENGAGED FROM THE SAFETY FEATURE."

    Patient problems: No Patient Involvement

    MAUDE report 8189017 ↗
  • MalfunctionDec 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT THE SYRINGE WITH SAFETY NEEDLE SAFETY MECHANISM IS FAULTY. THE SAFETY MECHANISM DID NOT CATCH AND THE NEEDLE FELL OUT AS SOON AS IT WAS OPENED. THERE WAS NO PATIENT IMPACT IT WAS PRETREATMENT. THE STAFF WAS PEELING OPEN UNUSED PRODUCT PREPPING FOR A FLU VACCINE. THERE WAS NO PROCEDURE IMPACT AS THE PRODUCT WAS NOT USED FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: IT WAS REPORTED THAT THE NEEDLE (STEEL FROM NEEDLE HUB) FELL OUT AS SOON AS IT WAS OPENED.

    Patient problems: No Patient Involvement

    MAUDE report 8189015 ↗
  • MalfunctionDec 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT THE SYRINGE WITH SAFETY NEEDLE SAFETY MECHANISM IS FAULTY. THE SAFETY MECHANISM DID NOT CATCH AND THE NEEDLE FELL OUT AS SOON AS IT WAS OPENED. THERE WAS NO PATIENT IMPACT IT WAS PRETREATMENT. THE STAFF WAS PEELING OPEN UNUSED PRODUCT PREPPING FOR A FLU VACCINE. THERE WAS NO PROCEDURE IMPACT AS THE PRODUCT WAS NOT USED FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: IT WAS REPORTED THAT THE NEEDLE (STEEL FROM NEEDLE HUB) FELL OUT AS SOON AS IT WAS OPENED.

    Patient problems: No Patient Involvement

    MAUDE report 8189012 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.