McKesson 102-N251SRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 30612479178855), received between Dec 29, 2017 and Oct 21, 2023 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2023Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED SAFETY NEEDLE WAS FAULTY AND RESULTED IN A NEEDLE STICK INJURY. BLOOD WORK HAS BEEN DRAWN FOR BOTH THE PATIENT AND STAFF. THE EVENT OCCURRED INTRA-OPERATIVE. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 28 SEP 2023: THE SHEATH MALFUNCTIONED. IT APPEARED TO BE ENGAGED HOWEVER IT WAS NOT. ALL LABS RELATED TO THE PATIENT WERE NEGATIVE. THE STAFF'S LABS WERE ALL NEGATIVE.

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

  MAUDE report 17982171 ↗
• MalfunctionApr 3, 2023Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE MEDICAL ASSISTANT (MA) WAS USING THE INVOLVED MCKESSON BRAND PREVENT HT SAFETY NEEDLE ,AND WHEN ACTIVATING THE SAFETY, SHE USED HER THUMB AND THE SHEATH MOVED TO THE SIDE AND INCURRED A NEEDLE STICK. THE EVENT OCCURRED POST-TREATMENT. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 08 MARCH 2023. THERE WAS NO BLOOD LOSS. THE PATIENT WAS STABLE. THE INJECTION WAS COMPLETED SUCCESSFULLY ON THE PATIENT. TESTING WAS PERFORMED ON THE NURSE WHO INCURRED THE NEEDLE STICK. THE TESTING WAS THE USUAL HIV, HEP-B AND HEP-C TESTING WAS PERFORMED ON THE NURSE AFTER THE NEEDLE STICK.

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

  MAUDE report 16666165 ↗
• MalfunctionNov 7, 2022Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT A FINGERSTICK WAS INCURRED RESULTING FROM THE INFERIOR SAFETY FUNCTION. IT TAKES AN EXCEPTIONAL AMOUNT OF FORCE TO PROPERLY CLICK THE SAFETY IN PLACE. IF ONE FINGER IS USED TO DEPLOY THE SAFETY AS INTENDED, IT SEEMS LIKE IT'S IN PLACE BUT EASILY POPS BACK OPEN. ADDITIONAL INFORMATION WAS RECEIVED ON 12 OCT 2022: THE ACTIVATION ATTEMPTED WAS VIA FINGER/THUMB AND PUSHING AGAINST A HARD SURFACE. PROCEDURE FOR THE PATIENT WAS PATIENT INJECTION. PATIENT WAS IN STABLE CONDITION. HEALTH CARE PROFESSIONAL BLOOD WAS DRAWN, AND PREVENTATIVE MEDICATION WAS TAKEN BY THE ASSOCIATE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15748958 ↗
• MalfunctionNov 5, 2022Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT A STAFF MEMBER EXPERIENCED CHALLENGES WITH ACTIVATING THE SAFETY WITH THE INVOLVED NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 07 OCTOBER 2022: IT WAS REPORTED THAT THE CHALLENGE THAT WAS FACED WITH ACTIVATION WAS THE SAFETY ACTIVATED HOWEVER IT WOULD NOT FULLY COVER THE NEEDLE. AFTER A STAFF MEMBER ACTIVATED THE NEEDLE, WHEN PLACING THE NEEDLE IN THE SHARP'S CONTAINER, THEIR FINGER WAS SCRATCHED ON THE NEEDLE. THE STAFF MEMBER DID ACTIVATE THE NEEDLE AGAINST A HARD SURFACE AS INDICATED IN IFU. HIV TESTING WAS PERFORMED AFTER THE NEEDLE TO ENSURE THE WELLBEING OF THE STAFF MEMBER. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE STAFF MEMBER IS STABLE/OK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15741024 ↗
• MalfunctionNov 5, 2022Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT A STAFF MEMBER EXPERIENCED CHALLENGES WITH ACTIVATING THE SAFETY WITH THE INVOLVED NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 07 OCTOBER 2022: IT WAS REPORTED THAT THE CHALLENGE THAT WAS FACED WITH ACTIVATION WAS THE SAFETY ACTIVATED HOWEVER IT WOULD NOT FULLY COVER THE NEEDLE. AFTER A STAFF MEMBER ACTIVATED THE NEEDLE, WHEN PLACING THE NEEDLE IN THE SHARP'S CONTAINER, THEIR FINGER WAS SCRATCHED ON THE NEEDLE. THE STAFF MEMBER DID ACTIVATE THE NEEDLE AGAINST A HARD SURFACE AS INDICATED IN IFU. HIV TESTING WAS PERFORMED AFTER THE NEEDLE TO ENSURE THE WELLBEING OF THE STAFF MEMBER. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE STAFF MEMBER IS STABLE/OK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15741021 ↗
• MalfunctionOct 27, 2022Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT A FINGERSTICK WAS INCURRED RESULTING FROM THE INFERIOR SAFETY FUNCTION. IT TAKES AN EXCEPTIONAL AMOUNT OF FORCE TO PROPERLY CLICK THE SAFETY IN PLACE. IF ONE FINGER IS USED TO DEPLOY THE SAFETY AS INTENDED, IT SEEMS LIKE IT'S IN PLACE BUT EASILY POPS BACK OPEN. ADDITIONAL INFORMATION WAS RECEIVED ON 12 OCT 2022: THE ACTIVATION ATTEMPTED WAS VIA FINGER/THUMB AND PUSHING AGAINST A HARD SURFACE. PROCEDURE FOR THE PATIENT WAS PATIENT INJECTION. PATIENT WAS IN STABLE CONDITION. HEALTH CARE PROFESSIONAL BLOOD WAS DRAWN, AND PREVENTATIVE MEDICATION WAS TAKEN BY THE ASSOCIATE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15685763 ↗
• MalfunctionOct 27, 2022Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT A FINGERSTICK WAS INCURRED RESULTING FROM THE INFERIOR SAFETY FUNCTION. IT TAKES AN EXCEPTIONAL AMOUNT OF FORCE TO PROPERLY CLICK THE SAFETY IN PLACE. IF ONE FINGER IS USED TO DEPLOY THE SAFETY AS INTENDED, IT SEEMS LIKE IT'S IN PLACE BUT EASILY POPS BACK OPEN. ADDITIONAL INFORMATION WAS RECEIVED ON 12 OCT 2022: THE ACTIVATION ATTEMPTED WAS VIA FINGER/THUMB AND PUSHING AGAINST A HARD SURFACE. PROCEDURE FOR THE PATIENT WAS PATIENT INJECTION. PATIENT WAS IN STABLE CONDITION. HEALTH CARE PROFESSIONAL BLOOD WAS DRAWN, AND PREVENTATIVE MEDICATION WAS TAKEN BY THE ASSOCIATE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15685682 ↗
• MalfunctionOct 18, 2022Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THAT THE INVOLVED NEEDLE IS VERY DANGEROUS AND HARD TO PUT THE SAFETY ON. AN ASSOCIATE ALMOST INCURRED A NEEDLE STICK. ADDITIONAL INFORMATION WAS RECEIVED ON 22 SEPT 2022: IT WAS REPORTED THAT THE NEEDLE WAS NEW FOR THE FACILITY. POST- SUCCESSFUL PATIENT FLU VACCINE. THE HEALTHCARE PROVIDER (HCP) HAD A NEAR MISS WITH THE SAFETY ACTIVATION. THE HCP WAS ACTIVATING IT ON A HARD SURFACE, WHEN THE NEEDLE BENT KEEPING IT FROM ACTIVATING, AND DID NOT GET STUCK. THERE WAS NO HEATH IMPACT TO THE ACTUAL PATIENT OR THE HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626302 ↗
• MalfunctionOct 11, 2022Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE SAFETY GUARD WOULD NOT ENGAGE LEAVING THE NEEDLE LEFT EXPOSED.

  Patient problems: Insufficient Information

  MAUDE report 15581847 ↗
• MalfunctionOct 11, 2022Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE SAFETY GUARD WOULD NOT ENGAGE LEAVING THE NEEDLE LEFT EXPOSED.

  Patient problems: Insufficient Information

  MAUDE report 15581788 ↗
• MalfunctionJul 19, 2022Activation Failure; Activation Problem; Activation Failure; Activation Problem

  THE USER FACILITY REPORTED THAT THE MCKESSON NEEDLE INVOLVED SAFETY DID NOT LOCK, AND A STAFF MEMBER INCURRED A NEEDLE STICK. ADDITIONAL INFORMATION WAS RECEIVED ON 29 JUN 2022: THE PATIENT WAS NOT AFFECTED DUE TO THE STICK. THE PATIENT PROCEDURE TAKING PLACE AT THE TIME THE DEVICE WAS BEING USED WAS A 25G NEEDLE FOR AN IM STEROID INJECTION. THE SAFETY NEEDLE WAS ACTIVATED ON A HARD SURFACE VISUALLY, HOWEVER A CLICK WAS NOT HEARD. HEALTH CARE PROVIDER (HCP) HAD BASIC FIRST AID AND LABS DRAWN AT OCCUPATIONAL A HEALTH CLINIC.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15060467 ↗
• MalfunctionJun 28, 2022Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT WHEN THE STAFF TRY TO CLOSE SAFETY DEVICE INVOLVED OVER THE NEEDLE, THE NEEDLE BENDS OUT AND CAUSES A NEEDLE STICK. THE NEEDLE ALMOST BENDS TO A 90-DEGREE ANGLE. THE EVENT OCCURRED INTRA-PROCEDURE. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT OR THE DID NOT RESULT IN A PATIENT INJURY AND OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14846874 ↗
• MalfunctionApr 28, 2022Activation Failure; Activation Problem; Activation Failure; Activation Problem

  THE USER FACILITY REPORTED THAT THE SAFETY ENGAGEMENT MALFUNCTION LED TO A NEEDLE STICK. THE STAFF MEMBER THOUGHT THE SAFETY WAS ENGAGED; HOWEVER, IT WAS NOT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE REPORTED PRODUCT WAS USED FOR A PATIENT INJECTION. WHEN THE STAFF MEMBER ATTEMPTED TO ENGAGE THE SAFETY, THEY THOUGHT THEY HEARD THE CLICK, AS INTENDED FOR SUCCESSFUL CONTAINMENT OF NEEDLE INTO SHEATH. THE STAFF MEMBER INCURRED A NEEDLE STICK BECAUSE THE DEVICE WAS NOT ENGAGED, AND THE EXPOSED NEEDLE STUCK THEM. THE NEEDLE STICK INJURY DID NOT REQUIRE MEDICAL INTERVENTION. A SIMPLE FIRST AID WASH/BAND-AID WAS APPLIED. THE PATIENT IN THE PROCEDURE ROOM WAS NOT IMPACTED IN ANY WAY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14241247 ↗
• MalfunctionApr 28, 2022Activation Failure; Activation Problem; Activation Failure; Activation Problem

  THE USER FACILITY REPORTED THAT THE SAFETY ENGAGEMENT MALFUNCTION LED TO A NEEDLE STICK. THE STAFF MEMBER THOUGHT THE SAFETY WAS ENGAGED; HOWEVER, IT WAS NOT. ADDITIONAL INFORMATION WAS RECEIVED ON 31 MAR 2022: THE REPORTED PRODUCT WAS USED FOR A PATIENT INJECTION. WHEN THE STAFF MEMBER ATTEMPTED TO ENGAGE THE SAFETY, THEY THOUGHT THEY HEARD THE CLICK, AS INTENDED FOR SUCCESSFUL CONTAINMENT OF NEEDLE INTO SHEATH. THE STAFF MEMBER INCURRED A NEEDLE STICK BECAUSE THE DEVICE WAS NOT ENGAGED, AND THE EXPOSED NEEDLE STUCK THEM. THE NEEDLE STICK INJURY DID NOT REQUIRE MEDICAL INTERVENTION. A SIMPLE FIRST AID WASH/BAND-AID WAS APPLIED. THE PATIENT IN THE PROCEDURE ROOM WAS NOT IMPACTED IN ANY WAY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14241163 ↗
• MalfunctionDec 1, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE SAFETY WAS NOT STAYING CLOSED AFTER THE INITIAL CLICK. MULTIPLE NURSES HAVE COMPLAINED ABOUT IT OPENING BACK UP. A NURSE TODAY THOUGHT THAT THE SAFETY WAS CLOSED HOWEVER IT OPENED AND THE NEEDLE STUCK THE NURSE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12911174 ↗
• MalfunctionDec 1, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE SAFETY WAS NOT STAYING CLOSED AFTER THE INITIAL CLICK. MULTIPLE NURSES HAVE COMPLAINED ABOUT IT OPENING BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911173 ↗
• MalfunctionNov 17, 2021Difficult to Insert; Material Too Soft/Flexible; Difficult to Insert; Material Too Soft/Flexible

  THE USER FACILITY REPORTED THAT THE NEEDLE WAS FLIMSY. THE STAFF INCURRED A NEEDLE STICK BECAUSE THE NEEDLE WAS DIFFICULT TO PUT INTO THE VIAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12832100 ↗
• MalfunctionNov 16, 2021Difficult to Insert; Material Too Soft/Flexible; Difficult to Insert; Material Too Soft/Flexible

  THE USER FACILITY REPORTED THAT THE NEEDLE WAS FLIMSY. THE STAFF INCURRED A NEEDLE STICK BECAUSE THE NEEDLE WAS DIFFICULT TO PUT INTO THE VIAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12822208 ↗
• MalfunctionNov 16, 2021Difficult to Insert; Material Too Soft/Flexible; Difficult to Insert; Material Too Soft/Flexible

  THE USER FACILITY REPORTED THAT THE NEEDLE WAS FLIMSY. THE STAFF INCURRED A NEEDLE STICK BECAUSE THE NEEDLE WAS DIFFICULT TO PUT INTO THE VIAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12822145 ↗
• MalfunctionSep 16, 2021Break; Malposition of Device; Material Twisted/Bent; Break; Malposition of Device; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT WHEN THE NEEDLE HAS BEEN USED, AND THE GREEN SAFETY COVER IS READY TO CLICK ONTO THE NEEDLE, THE SAFETY COVER BREAKS OFF AND THE NEEDLE BENDS. ADDITIONAL INFORMATION WAS RECEIVED ON 23AUGUST2021: NO NEEDLE STICK OCCURRED DURING THE EVENT. IT APPEARS TO BE A SHEATH ACTIVATION PROBLEM. PER THE PHYSICIAN, AFTER ADMINISTERING THE VACCINE, SHE PRESSED DOWN TO LOCK IN THE SAFETY SHEATH, AND IT SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12483300 ↗
• MalfunctionSep 16, 2021Break; Malposition of Device; Material Twisted/Bent; Break; Malposition of Device; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT WHEN THE NEEDLE HAS BEEN USED, AND THE GREEN SAFETY COVER IS READY TO CLICK ONTO THE NEEDLE, THE SAFETY COVER BREAKS OFF AND THE NEEDLE BENDS. ADDITIONAL INFORMATION WAS RECEIVED ON 23AUGUST2021: NO NEEDLE STICK OCCURRED DURING THE EVENT. IT APPEARS TO BE A SHEATH ACTIVATION PROBLEM. PER THE PHYSICIAN, AFTER ADMINISTERING THE VACCINE, SHE PRESSED DOWN TO LOCK IN THE SAFETY SHEATH, AND IT SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482446 ↗
• MalfunctionSep 16, 2021Break; Malposition of Device; Material Twisted/Bent; Break; Malposition of Device; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT WHEN THE NEEDLE HAS BEEN USED, AND THE GREEN SAFETY COVER IS READY TO CLICK ONTO THE NEEDLE, THE SAFETY COVER BREAKS OFF AND THE NEEDLE BENDS. ADDITIONAL INFORMATION WAS RECEIVED ON 23AUGUST2021: NO NEEDLE STICK OCCURRED DURING THE EVENT. IT APPEARS TO BE A SHEATH ACTIVATION PROBLEM. PER THE PHYSICIAN, AFTER ADMINISTERING THE VACCINE, SHE PRESSED DOWN TO LOCK IN THE SAFETY SHEATH, AND IT SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482445 ↗
• MalfunctionSep 10, 2021Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THAT THE STAFF FOUND A FAILURE IN THE SAFETY MECHANISM FOR THE NEEDLE. IT DOES NOT SNAP INTO THE LOCK POSITION IN A SMOOTH FASHION CAUSING NEEDLE STICKS. ADDITIONAL INFORMATION WAS RECEIVED ON 13AUGUST2021: AN HCP ON STAFF INCURRED A NEEDLE STICK WHILE ATTEMPTING ACTIVATION. THE HCP STATED IT WAS DIFFICULT TO CAPTURE INSIDE THE SAFETY (TOOTH). ACTIVATION WAS ATTEMPTED WITH THE FINGER. NO MEDICAL TREATMENT WAS REQUIRED BEYOND A BAND-AID. THE PATIENT WAS NOT AFFECTED IN EITHER CASE AND RECEIVED INJECTION/BLOOD DRAW AS INTENDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12452096 ↗
• MalfunctionSep 10, 2021Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THAT THE STAFF FOUND A FAILURE IN THE SAFETY MECHANISM FOR THE NEEDLE. IT DOES NOT SNAP INTO THE LOCK POSITION IN A SMOOTH FASHION CAUSING NEEDLE STICKS. ADDITIONAL INFORMATION WAS RECEIVED ON 13AUGUST2021: AN HCP ON STAFF INCURRED A NEEDLE STICK WHILE ATTEMPTING ACTIVATION. THE HCP STATED IT WAS DIFFICULT TO CAPTURE INSIDE THE SAFETY (TOOTH). ACTIVATION WAS ATTEMPTED WITH THE FINGER. NO MEDICAL TREATMENT WAS REQUIRED BEYOND A BAND-AID. THE PATIENT WAS NOT AFFECTED IN EITHER CASE AND RECEIVED INJECTION/BLOOD DRAW AS INTENDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12452095 ↗
• MalfunctionAug 3, 2020Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE NURSE'S LEFT THUMB WAS SCRATCHED BY A NEEDLE WHEN ITS SAFETY CAP MALFUNCTIONED. ADDITIONAL INFORMATION WAS RECEIVED ON 14JULY2020: IT WAS REPORTED THAT THE HYPODERMIC NEEDLE MALFUNCTIONED, THE NEEDLE SLIPPED OUT AND SCRATCHED HER LEFT THUMB AFTER ADMINISTERING THE INJECTION. THE NURSE WAS ABLE TO COMPLETE TREATMENT ON THE PATIENT RECEIVING THE INJECTION. THE NURSE FOLLOWED-UP WITH A STANDARD BLOODWORK ON THE FOLLOWING DAY WHERE NO BLOOD CONTAMINATION WAS DETECTED. SHE WILL HAVE A 6 WEEK AND 6-MONTH FOLLOW-UP TO CONFIRM NO INFECTION FROM CONTAMINATED NEEDLE.

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

  MAUDE report 10355017 ↗