McKesson 26547Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479201054), received between Dec 26, 2019 and Mar 8, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• MalfunctionMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE THREAD ON THE SYRINGE DOES NOT APPEAR DEEP ENOUGH TO HOLD THE NEEDLE IN PLACE. THE SYRINGE HAS COME OFF 3 TIMES WHILE ADMINISTERING THICKER INJECTIONS, CAUSING NEEDLE TO REMAIN IN PATIENT'S LEG. PER ADDITIONAL INFORMATION RECEIVED, THE NEEDLE WAS IMMEDIATELY REMOVED WITHOUT ANY FURTHER INTERVENTIONS NEEDED. THE NEEDLE AND HUB REMAINED INTACT, TOGETHER, THEY DETACHED FROM THE LUER OF THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693328 ↗
• MalfunctionJan 20, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED, THE LUER TIP OF THE DEVICE WAS DETACHED INSIDE THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 9608625 ↗
• MalfunctionDec 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE NURSE FOUND MEDICATION DRIPPING DOWN THE PATIENT'S ARM AND NOTICED THE NEEDLE WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520908 ↗