McKesson 4666Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20612479204342), received between Aug 23, 2017 and Aug 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2017Difficult to Open or Close; Difficult to Open or Close

  THE USER FACILITY REPORTED THAT THE SAFETY COVER IS HINGED TO THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: IT DOES NOT POP ONTO THE NEEDLE TO COVER IT EASILY; TO BE ABLE TO USE THE SAFETY COVER YOU HAVE TO TURN IT OVER, AND IN THAT PROCESS THAT HINGE DOES NOT ALWAYS WORK CORRECTLY AND WILL CAUSE THE NEEDLE TO FLIP BACK ONTO YOU; THIS IS USING A ONE HANDED PROCEDURE; WHEN THEY ARE TRYING TO ACTIVATE IT ON A TABLE, IT HAS A CUSHIONED TOP, SO YOU HAVE TO PUSH VERY HARD TO TRY TO ACTIVATE IT INTO THE SAFETY SHIELD; SOMETIMES IT DOES NOT STAY IN THE SHIELD, SO THAT IS WHAT IS MEANT BY NEEDLE POPPING BACK; THE NEEDLE DOES NOT SPRING BACK, IT IS NOT ALWAYS IN THE SAFETY SHIELD AS IT SHOULD BE AFTER PUSHING DOWN; THIS DID NOT IMPACT ANY INFUSION PROCESS WITH ANY PATIENTS DURING USE; THEY HAVE NOT HAD ANY NEEDLE STICKS, DUE TO THE DIFFICULTY, THEY JUST FELT IT WAS AWKWARD TO USE; THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 2, 2017. THIS WAS THE FIRST BOX OF THE STATED PRODUCT THAT THEY HAVE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6813799 ↗