McKesson 102-SNT1C2558SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20612479180646), received between Jul 26, 2019 and Oct 26, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER FACILITY REPORTED THAT THE INVOLVED MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE SYRINGE DETACHED FROM THE NEEDLE AND THE NEEDLE HAD TO BE PULLED OUT SEPARATELY. THIS HAPPENED WHEN A VACCINE WAS BEING ADMINISTERED TO A (B)(6) YEAR OLD CHILD, THEY WERE UNABLE TO ACTIVATE THE SAFETY DEVICE UNTIL THE THIRD TRY BECAUSE THEY DID NOT HAVE A NEARBY HARD SURFACE. PEDIATRICS PATIENT WAS UNAFFECTED, AND THE HEALTH CARE PROFESSIONAL WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 05OCTOBER021: THERE WAS NO PATIENT INJURY OR NEEDLE STICKS DUE THE ISSUE REPORTED. PATIENT RECEIVED THE VACCINE AS INTENDED. THEY USED THE SAME NEEDLE TO ASPIRATE THE VACCINE AS IT WAS INJECTED INTO THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS THE NEEDLE WAS PULLED OUT SEPARATELY FROM SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699595 ↗
• MalfunctionOct 26, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER FACILITY REPORTED THAT THE INVOLVED MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE SYRINGE DETACHED FROM THE NEEDLE AND THE NEEDLE HAD TO BE PULLED OUT SEPARATELY. THIS HAPPENED WHEN A VACCINE WAS BEING ADMINISTERED TO A (B)(6) CHILD, THEY WERE UNABLE TO ACTIVATE THE SAFETY DEVICE UNTIL THE THIRD TRY BECAUSE THEY DID NOT HAVE A NEARBY HARD SURFACE. PEDIATRICS PATIENT WAS UNAFFECTED, AND THE HEALTH CARE PROFESSIONAL WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED ON 05OCTOBER021: THERE WAS NO PATIENT INJURY OR NEEDLE STICKS DUE THE ISSUE REPORTED. PATIENT RECEIVED THE VACCINE AS INTENDED. THEY USED THE SAME NEEDLE TO ASPIRATE THE VACCINE AS IT WAS INJECTED INTO THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS THE NEEDLE WAS PULLED OUT SEPARATELY FROM SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699582 ↗
• MalfunctionJul 26, 2019Activation Problem; Activation Problem

  THE USER FACILITY REPORTED A COMPONENT RETENTION ISSUE WITH THE HYPODERMIC NEEDLE. THE MEDICAL ASSISTANT STATED THAT SHE HAD EXPERIENCED DIFFICULTY USING THE SAFETY FEATURE ON THE REPORTED PRODUCT. SHE STATED IT WOULD NOT PUSH INTO THE SAFETY AS IT WAS SUPPOSED TO WHEN ACTIVATING. THE DIFFICULTY WAS SPECIFICALLY ACTIVATING THE SAFETY FEATURE USING BOTH, A TABLE TOP AND WITH HER FINGER. NO NEEDLE STICKS OCCURRED DUE TO THIS ISSUE, AND NO PATIENTS WERE AFFECTED BY THE ISSUE POST INJECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830661 ↗