McKesson 102-N231SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30612479178763), received between Dec 8, 2017 and Mar 24, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (6 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2023Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT INVOLVED MCKESSON PREVENT ® HT SAFETY HYPODERMIC NEEDLE SAFETY LOCK DID NOT LOCK IN PLACE RESULTING TO A NEEDLE STICK. THE NURSE WAS PRICKED IN THE FINGER WITH THE DIRTY NEEDLE BECAUSE THE SAFETY LOCK DID NOT LOCK IN PLACE WHEN THEY CLOSED IT AFTER GIVING AN INJECTION. ADDITIONAL INFORMATION WAS RECEIVED ON 28 FEB 2023: THE PROCEDURE WAS COMPLETED AS INTENDED WITHOUT IMPACT. THE EMPLOYEE HAD TO HAVE BLOOD WORK DONE, ALONG WITH THE PATIENT. THE EMPLOYEE WAS STARTED ON A PROPHYLACTIC TREATMENT UNTIL THE LAB RESULTS CAME BACK. THE STAFF MEMBER WAS ABLE TO RETURN TO THEIR NORMAL DUTIES POST NEEDLE STICK EVENT. THE METHOD OF ACTIVATION THE STAFF MEMBER USED WAS UNKNOWN. IT WAS UNKNOWN IF THE NEEDLE HAD ANY SIGNS OF DAMAGE TO IT. THE EMPLOYEE WAS GIVEN VACCINES WHEN THE INCIDENT OCCURRED. EQUIPMENT OR OTHER DEVICES USED WITH THE NEEDLE WAS 3ML SYRINGE.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610264 ↗
• MalfunctionMar 24, 2023Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT INVOLVED MCKESSON PREVENT ® HT SAFETY HYPODERMIC NEEDLE SAFETY LOCK DID NOT LOCK IN PLACE RESULTING TO A NEEDLE STICK. THE NURSE WAS PRICKED IN THE FINGER WITH THE DIRTY NEEDLE BECAUSE THE SAFETY LOCK DID NOT LOCK IN PLACE WHEN THEY CLOSED IT AFTER GIVING AN INJECTION. ADDITIONAL INFORMATION WAS RECEIVED ON 28 FEB 2023: THE PROCEDURE WAS COMPLETED AS INTENDED WITHOUT IMPACT. THE EMPLOYEE HAD TO HAVE BLOOD WORK DONE, ALONG WITH THE PATIENT. THE EMPLOYEE WAS STARTED ON A PROPHYLACTIC TREATMENT UNTIL THE LAB RESULTS CAME BACK. THE STAFF MEMBER WAS ABLE TO RETURN TO THEIR NORMAL DUTIES POST NEEDLE STICK EVENT. THE METHOD OF ACTIVATION THE STAFF MEMBER USED WAS UNKNOWN. IT WAS UNKNOWN IF THE NEEDLE HAD ANY SIGNS OF DAMAGE TO IT. THE EMPLOYEE WAS GIVEN VACCINES WHEN THE INCIDENT OCCURRED. EQUIPMENT OR OTHER DEVICES USED WITH THE NEEDLE WAS 3ML SYRINGE.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610263 ↗
• MalfunctionNov 19, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE SAFETY CAP DID NOT ENGAGE. THIS HAPPENED DURING A FLU CLINIC. AT LEAST 20 OF THE NEEDLE'S HAD SAFETY FUNCTIONS. MALFUNCTIONED-SAFETY CAP DID NOT ENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843764 ↗
• MalfunctionNov 19, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE SAFETY CAP DID NOT ENGAGE. THIS HAPPENED DURING A FLU CLINIC. AT LEAST 20 OF THE NEEDLE'S HAD SAFETY FUNCTIONS. MALFUNCTIONED-SAFETY CAP DID NOT ENGAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843674 ↗
• MalfunctionApr 7, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  THE USER FACILITY REPORTED THE ONE OF THE STAFF MEMBERS SUFFERED A NEEDLE STICK WITH THIS ITEM. THE ISSUE WITH THE PRODUCT WAS THAT THE SAFETY MECHANISM DID NOT CLOSE COMPLETELY OVER THE NEEDLE CAUSING CONFUSION ON WHETHER THE NEEDLE WAS SECURED INSIDE OF THE SAFETY. ADDITIONAL INFORMATION WAS RECEIVED ON 19MARCH2021: THE HCP ACTIVATED THE DEVICE AGAINST A HARD SURFACE, POST PATIENT VACCINE, AND WHEN HE PICKED IT BACK UP THE SAFETY NEEDLE HAD NOT BEEN LOCKED IN, AND HE INCURRED A NEEDLE STICK. PER FACILITY PROTOCOL HE WAS SENT TO HOSPITAL FOR BBP EXPOSURE TESTING AND WAS CLEARED TO RETURN TO WORK THE NEXT DAY. THE ACTUAL PATIENT WHO RECEIVED THE VACCINE WAS NOT AFFECTED. HE HAS COMPLETED THE REQUIRED 1 WEEK FOLLOW UP AT HOSPITAL ON (B)(6) 2021 AND IS HEALTHY AND CLEARED COMPLETELY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11626986 ↗
• MalfunctionFeb 5, 2021Improper or Incorrect Procedure or Method; Activation Problem; Improper or Incorrect Procedure or Method; Activation Problem

  THE USER FACILITY REPORTED THEY HAD A NEEDLE STICK INJURY WHEN A NURSE WENT TO ENGAGE THE SAFETY CAP. ADDITIONAL INFORMATION WAS RECEIVED ON 15JANUARY2021: THE PATIENT DID RECEIVE THEIR INTENDED FLU SHOT AND WAS NOT IMPACTED. THE NURSE WAS STUCK WHILE ATTEMPTING TO ACTIVATE INTO SAFETY SHEATH, POST INJECTION. THE NURSE REQUIRED NO MEDICAL INTERVENTION, JUST SIMPLE FIRST AID, AS THE PATIENT WAS CONFIRMED FREE FROM INFECTIOUS DISEASE. THE STAFF WAS NOT FAMILIAR WITH THE TERUMO SAFETY NEEDLE AND HAD BEEN USING B-D SAFETY NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 21JANUARY2021: SHE (NURSE) DID NOT ACTIVATE THE NEEDLE ON A HARD SERVICE.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287850 ↗
• MalfunctionOct 29, 2020Improper or Incorrect Procedure or Method; Activation Problem; Improper or Incorrect Procedure or Method; Activation Problem

  THE USER FACILITY REPORTED THAT THE USER WAS TRYING TO ACTIVATE THE DEVICE WITH AN UNINTENDED METHOD BY THUMB, AND EXPERIENCED A NEEDLE STICK. THERE WAS NO PATIENT INJURY/MEDICAL, OR SURGICAL INTERVENTION. NO PATIENT WAS IMPACTED. ADDITIONAL INFORMATION WAS RECEIVED ON 09 OCTOBER 2020: AFTER ASPIRATING THE MEDICATION, THE USER THEN ATTEMPTED TO PUSH THE SHEATH CLOSED WITH HER THUMB TO ACTIVATE, SHE WAS THEN "SCRATCHED" WITH THE TIP OF THE NEEDLE, AS SHE STATED HER THUMB "SLID ACROSS THE NEEDLE". IT WAS STATED THAT THEY ASPIRATE MEDICATION WITH ONE NEEDLE, THEN CHANGE TO A NEW NEEDLE FOR INJECTION. THIS OCCURRED PRIOR TO ANY PATIENT PROCEDURE, DURING PREPARATION OF VIAL WITH MEDICATION. IT WAS A MINOR SCRATCH AND NO TREATMENT WAS REQUIRED. SHE STATED SHE JUST APPLIED A BAND-AID ON THE SCRATCH SINCE THERE WAS NO RISK OF INFECTIOUS DISEASE. SHE STATED SHE UNDERSTANDS NOW, NOT TO ATTEMPT ACTIVATION WITH THIS PRODUCT, EXCEPT ON HARD SURFACE WITH FINGERS BEHIND THE NEEDLE AT ALL TIMES. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO IMPACT ON THE PROCEDURE. THE USER THAT INCURRED THE NEEDLE STICK DID NOT REQUIRE ANY MEDICAL TREATMENT.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10754723 ↗
• MalfunctionDec 17, 2019Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE THAT INCURRED A NEEDLE STICK BECAUSE THE MCKESSON BRAND SAFETY NEEDLE WAS DIFFICULT TO CLOSE. THE GREEN SAFETY HINGE THAT COVERS THE NEEDLE USUALLY IS FLIPPED AND CLOSED WHILE PUSHING AGAINST THE PATIENT TABLE, AS TO DISPOSE OF WITH NEEDLE COVERED TO BE SAFE. HOWEVER, THE COVER IS NOT CLOSING EASILY AND FLIPS BACK UP WITH THE NEEDLE STILL OUT, STICKING THE NURSE. ADDITIONAL INFORMATION WAS RECEIVED 19NOVERMBER2019: NO NURSES SOUGHT MEDICAL TREATMENT. THERE WERE NO RISKS OF INFECTIOUS DISEASE. THE PATIENTS PAST MEDICAL HISTORY INDICATES ANY POTENTIAL INFECTIOUS DISEASE WHICH A NURSE WOULD BE EXPOSED TO BY BLOOD BOURNE PATHOGENS. NONE OF THE PEDIATRIC PATIENTS HAD ANY INFECTIOUS DISEASES. THE NURSES WAS STUCK WHEN THE NEEDLE POKED THEM THROUGH THE FINGER OR INTO THEIR CUTICLE. THE DIRTY NEEDLES GO INTO A BIOHAZARD CONTAINER WHICH IS THEN INCINERATED BY A WASTE MANAGEMENT COMPANY.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 9483687 ↗
• MalfunctionDec 16, 2019Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE THAT INCURRED A NEEDLE STICK BECAUSE THE MCKESSON BRAND SAFETY NEEDLE WAS DIFFICULT TO CLOSE. THE GREEN SAFETY HINGE THAT COVERS THE NEEDLE USUALLY IS FLIPPED AND CLOSED WHILE PUSHING AGAINST THE PATIENT TABLE, AS TO DISPOSE OF WITH NEEDLE COVERED TO BE SAFE. HOWEVER, THE COVER IS NOT CLOSING EASILY AND FLIPS BACK UP WITH THE NEEDLE STILL OUT, STICKING THE NURSE. ADDITIONAL INFORMATION WAS RECEIVED 19NOVERMBER2019: NO NURSES SOUGHT MEDICAL TREATMENT. THERE WERE NO RISKS OF INFECTIOUS DISEASE. THE PATIENTS PAST MEDICAL HISTORY INDICATES ANY POTENTIAL INFECTIOUS DISEASE WHICH A NURSE WOULD BE EXPOSED TO BY BLOOD BOURNE PATHOGENS. NONE OF THE PEDIATRIC PATIENTS HAD ANY INFECTIOUS DISEASES. THE NURSES WAS STUCK WHEN THE NEEDLE POKED THEM THROUGH THE FINGER OR INTO THEIR CUTICLE. THE DIRTY NEEDLES GO INTO A BIOHAZARD CONTAINER WHICH IS THEN INCINERATED BY A WASTE MANAGEMENT COMPANY.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 9474269 ↗
• MalfunctionDec 16, 2019Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE THAT INCURRED A NEEDLE STICK BECAUSE THE MCKESSON BRAND SAFETY NEEDLE WAS DIFFICULT TO CLOSE. THE GREEN SAFETY HINGE THAT COVERS THE NEEDLE USUALLY IS FLIPPED AND CLOSED WHILE PUSHING AGAINST THE PATIENT TABLE, AS TO DISPOSE OF WITH NEEDLE COVERED TO BE SAFE. HOWEVER, THE COVER IS NOT CLOSING EASILY AND FLIPS BACK UP WITH THE NEEDLE STILL OUT, STICKING THE NURSE. ADDITIONAL INFORMATION WAS RECEIVED 19NOVERMBER2019: NO NURSES SOUGHT MEDICAL TREATMENT. THERE WERE NO RISKS OF INFECTIOUS DISEASE. THE PATIENTS PAST MEDICAL HISTORY INDICATES ANY POTENTIAL INFECTIOUS DISEASE WHICH A NURSE WOULD BE EXPOSED TO BY BLOOD BOURNE PATHOGENS. NONE OF THE PEDIATRIC PATIENTS HAD ANY INFECTIOUS DISEASES. THE NURSES WAS STUCK WHEN THE NEEDLE POKED THEM THROUGH THE FINGER OR INTO THEIR CUTICLE. THE DIRTY NEEDLES GO INTO A BIOHAZARD CONTAINER WHICH IS THEN INCINERATED BY A WASTE MANAGEMENT COMPANY.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 9474267 ↗
• MalfunctionDec 16, 2019Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE THAT INCURRED A NEEDLE STICK BECAUSE THE MCKESSON BRAND SAFETY NEEDLE WAS DIFFICULT TO CLOSE. THE GREEN SAFETY HINGE THAT COVERS THE NEEDLE USUALLY IS FLIPPED AND CLOSED WHILE PUSHING AGAINST THE PATIENT TABLE, AS TO DISPOSE OF WITH NEEDLE COVERED TO BE SAFE. HOWEVER, THE COVER IS NOT CLOSING EASILY AND FLIPS BACK UP WITH THE NEEDLE STILL OUT, STICKING THE NURSE. ADDITIONAL INFORMATION WAS RECEIVED 19NOVERMBER2019: NO NURSES SOUGHT MEDICAL TREATMENT. THERE WERE NO RISKS OF INFECTIOUS DISEASE. THE PATIENTS PAST MEDICAL HISTORY INDICATES ANY POTENTIAL INFECTIOUS DISEASE WHICH A NURSE WOULD BE EXPOSED TO BY BLOOD BOURNE PATHOGENS. NONE OF THE PEDIATRIC PATIENTS HAD ANY INFECTIOUS DISEASES. THE NURSES WAS STUCK WHEN THE NEEDLE POKED THEM THROUGH THE FINGER OR INTO THEIR CUTICLE. THE DIRTY NEEDLES GO INTO A BIOHAZARD CONTAINER WHICH IS THEN INCINERATED BY A WASTE MANAGEMENT COMPANY.

  Patient problems: Needle Stick/Puncture; No Consequences Or Impact To Patient

  MAUDE report 9474261 ↗
• MalfunctionDec 8, 2017Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT THE DEVICE BENDS BACK TOWARD THE USER WHEN THE SAFETY IS INITIATED. IT WAS REPORTED THAT THE NEEDLE WAS NOT BENT PRIOR TO ACTIVATION OF SAFETY DEVICE. THE SAFETY NEEDLES WAS ACTIVATED AGAINST A HARD FLAT SURFACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7099098 ↗
• MalfunctionDec 8, 2017Use of Device Problem; Use of Device Problem

  THE (B)(4) REPORTED THAT THE DEVICE BENDS BACK TOWARD THE USER WHEN THE SAFETY IS INITIATED. IT WAS REPORTED THAT THE NEEDLE WAS NOT BENT PRIOR TO ACTIVATION OF SAFETY DEVICE. THE SAFETY NEEDLES WAS ACTIVATED AGAINST A HARD FLAT SURFACE.

  Patient problems: No Patient Involvement

  MAUDE report 7099075 ↗