McKesson 102-N25105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30612479178886), received between Nov 19, 2019 and Dec 7, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2022Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE NEEDLE INVOLVED SEEMED FAULTY. THE STAFF HAS NOTICED THAT OFTEN, THE NEEDLE DOESN'T CORRECTLY LOCK AFTER USE, EVEN IF IT CLICKED, WHICH LEAD TO THE THOUGHT OF THE NEEDLE BEING LOCKED AND COVERED, HOWEVER WAS NOT. THIS HAS LED TO A NEEDLE STICK INJURY AND IS A SAFETY ISSUE. ADDITIONAL INFORMATION RECEIVED 21 NOV 2022: THERE WAS NO BLOOD LOSS. THE PATIENT WAS IN STABLE CONDITION. TESTING WAS PERFORMED DUE TO THE NEEDLE STICK, A HEP PANEL AND HIV. THE INJECTION WAS COMPLETED AS INTENDED. THE STAFF MEMBER ACTIVATED THE NEEDLE AGAINST A HARD SURFACE AS INDICATED IN INSTRUCTIONS FOR USE (IFU).

  Patient problems: Needle Stick/Puncture

  MAUDE report 15936631 ↗
• MalfunctionDec 7, 2022Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE NEEDLE INVOLVED SEEMED FAULTY. THE STAFF HAS NOTICED THAT OFTEN, THE NEEDLE DOESN'T CORRECTLY LOCK AFTER USE, EVEN IF IT CLICKED, WHICH LEAD TO THE THOUGHT OF THE NEEDLE BEING LOCKED AND COVERED, HOWEVER WAS NOT. THIS HAS LED TO A NEEDLE STICK INJURY AND IS A SAFETY ISSUE. ADDITIONAL INFORMATION RECEIVED 21 NOV 2022: THERE WAS NO BLOOD LOSS. THE PATIENT WAS IN STABLE CONDITION. TESTING WAS PERFORMED DUE TO THE NEEDLE STICK, A HEP PANEL AND HIV. THE INJECTION WAS COMPLETED AS INTENDED. THE STAFF MEMBER ACTIVATED THE NEEDLE AGAINST A HARD SURFACE AS INDICATED IN INSTRUCTIONS FOR USE (IFU).

  Patient problems: Needle Stick/Puncture

  MAUDE report 15936614 ↗
• MalfunctionMay 5, 2022Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE CUSTOMER HAD A SAFETY AND QUALITY ISSUE WITH THE NEEDLE MCKESSON NEEDLE INVOLVED. A STAFF MEMBER INCURRED A NEEDLE STICK. THIS WAS A RESULT OF THE SAFETY DEVICE NOT STAYING CLOSED AND POPPING OPEN. THERE WAS NO PATIENT BLOOD LOSS. THERE WAS NO PATIENT INJURY AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. THERE IS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 08 APR 2022: IT WAS CLICKED CLOSED HOWEVER IT WOULD NOT STAY CLOSED, IT WOULD BECOME DISENGAGED AND WOULD POP OPEN. THE USER USED THEIR THUMB TO CLOSE IT. IT WAS STATED THAT THEY HAD TO PRESS VERY HARD BECAUSE THE DEVICE IS HARD TO ACTIVATE. WITHIN THE INITIAL INFORMATION THE STATEMENT THAT THE SAFETY DEVICE WOULD NOT STAY CLOSED MEANS IT DEACTIVATED. ADDITIONAL INFORMATION RECEIVED 11 APR 2022: THE STAFF MEMBER STUCK BY THE NEEDLE IS IN STABLE CONDITION. A BASELINE LAB DRAWS WAS DONE ON THE NEEDLE STICK INJURY. EVERYTHING WAS NORMAL FOR THE FIRST DRAW AND WILL BE REDRAWN AGAIN IN 6 MONTHS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14287495 ↗
• MalfunctionMay 5, 2022Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE CUSTOMER HAD A SAFETY AND QUALITY ISSUE WITH THE NEEDLE MCKESSON NEEDLE INVOLVED. A STAFF MEMBER INCURRED A NEEDLE STICK. THIS WAS A RESULT OF THE SAFETY DEVICE NOT STAYING CLOSED AND POPPING OPEN. THERE WAS NO PATIENT BLOOD LOSS. THERE WAS NO PATIENT INJURY AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. THERE IS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 08 APR 2022: IT WAS CLICKED CLOSED HOWEVER IT WOULD NOT STAY CLOSED, IT WOULD BECOME DISENGAGED AND WOULD POP OPEN. THE USER USED THEIR THUMB TO CLOSE IT. IT WAS STATED THAT THEY HAD TO PRESS VERY HARD BECAUSE THE DEVICE IS HARD TO ACTIVATE. WITHIN THE INITIAL INFORMATION THE STATEMENT THAT THE SAFETY DEVICE WOULD NOT STAY CLOSED MEANS IT DEACTIVATED. ADDITIONAL INFORMATION RECEIVED 11 APR 2022: THE STAFF MEMBER STUCK BY THE NEEDLE IS IN STABLE CONDITION. A BASELINE LAB DRAWS WAS DONE ON THE NEEDLE STICK INJURY. EVERYTHING WAS NORMAL FOR THE FIRST DRAW AND WILL BE REDRAWN AGAIN IN 6 MONTHS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14287433 ↗
• MalfunctionApr 28, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THE MCKESSON NEEDLE WOULD NOT CLOSE ALL THE WAY. A NURSE SUFFERED A NEEDLE STICK DUE TO THE NEEDLE NOT CLOSING ALL THE WAY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11736756 ↗
• MalfunctionApr 27, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THE MCKESSON NEEDLE WOULD NOT CLOSE ALL THE WAY. THE NURSE SUFFERED A NEEDLE STICK DUE TO THIS ISSUE. THE NURSES REPORTED THAT THESE NEEDLES ARE HARD TO CLOSE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11733588 ↗
• MalfunctionNov 19, 2019Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT THE SAFETY CAP WAS FLIMSY. IT WAS REPORTED THAT WHEN THEY FOLDED THE SAFETY CAP OVER THE NEEDLE IT GOES TO THE SIDE OF THE NEEDLE INSTEAD OF OVER IT AND POKES YOU. A MEDICAL ASSISTANT INCURRED A NEEDLE STICK BECAUSE OF IT. ADDITIONAL INFORMATION WAS RECEIVED 29OCTOBER2019: THE NEEDLE STICK OCCURRED DURING A VACCINE PREP, WITH THE NEW NEEDLE BEING ATTACHED. THE NEEDLE PROCTOR FELL OFF DURING NEEDLE ATTACHMENT WITH VACCINE SYRINGE AND THE MEDICAL ASSISTANT WAS STUCK INADVERTENTLY. IT WAS A CLEAN NEEDLE STICK, WHICH DID NOT REQUIRE ANY MEDICAL TREATMENT. WHEN THE MEDICAL ASSISTANT TRIED TO ACTIVATE THE UNPROTECTED NEEDLE INTO SAFETY, SHE NOTICED IT DID NOT EASILY ACTIVATE INTO THE SHEATH AGAINST HARD SURFACE, SHE WAS NOT STUCK DURING ACTIVATION, JUST HAD DIFFICULTY WITH PUSHING INTO THE SHEATH. THEY WERE USING BECTON DICKENSON SAFETY, AND THESE WERE NEW PRODUCT FOR THE FACILITY."

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

  MAUDE report 9340460 ↗