Monoject 8506YRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521023260), received between Oct 6, 2021 and Feb 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE STAFF HAD A NEAR MISS (NEEDLE STICK) WHEN TRYING TO PUSH THE VACUTAINER IN. THE CONTAINER THAT WAS NOT OVERFILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315285 ↗
• MalfunctionFeb 7, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER STATES AN EMPLOYEE REPORTED THAT THERE WAS A BLOODWORK NEEDLE STICKING (NOT RETRACTED) OUT OF THE SHARPS CONTAINER, WHILE WRITER WAS DISPOSING IV SHARPS AND WAS SUBSEQUENTLY POKED. THERE WAS A VACUTAINER THAT HAD NOT FALLEN COMPLETELY IN THE CONTAINER AND THE TUMBLER HAD NOT ENGAGED. THE STAFF DIDN¿T SEE THE NEEDLE STICKING OUT AND REACHED FOR THE CONTAINER. THEY SAID THAT THE CONTAINER WAS NOT FULL. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 STATED THAT AS A PRECAUTION THE EMPLOYEE WENT TO EMERGENCY AND SAW A PHYSICIAN. THEY ALSO HAD BLOOD WORK DONE AS A PRECAUTION, THE RESULTS ARE NOT AVAILABLE.

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

  MAUDE report 16315077 ↗
• MalfunctionOct 14, 2021Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT THIS PERMANENT SUBSTITUTE IS VERY DIFFICULT TO USE DUE TO THE SMALL OPENING AND THE COUNTER-BALANCED LID. THE STAFF SPENDS EXCESS TIME ENSURING THE SHARPS DESCEND INTO THE CONTAINER. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT THEY DO NOT LIKE THE DESIGN OF THE COUNTER-BALANCED LID. THE LID IS SLOW TO ACCEPT ITEMS. THEY STOCK THESE CONTAINERS SO THEY HAVE MANY. WHEN SYRINGES WITH LABELS ATTACHED FROM THE OMNICELL ARE PLACED IN THE SHARPS CONTAINERS, THE LABELS END UP STICKING TO THE SIDES OF THE OPENING PREVENTING OTHER ITEMS FROM DROPPING IN. WHEN DEPOSITING LARGE ITEMS, LIKE CVC SHARPS AND NEEDLE/SYRINGES USED TO PERFORM BLOCKS, THE ITEMS GET STUCK IN THE NARROW OPENING. STAFF HAS TO SHAKE AND KNOCK THE CONTAINERS TO GET ITEMS TO FALL IN. THEY DID NOT HAVE ANY OF THESE ISSUES WITH THE OPEN LID DESIGN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12635854 ↗
• MalfunctionOct 6, 2021Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE COUNTER-BALANCED LID ON THE SHARPS CONTAINER GETS STUCK AND JAMS. SHARPS ARE NOT COMPLETELY DEPOSITED INTO CONTAINER AND SHARPS ARE LEFT EXPOSED WHICH INCREASES RISK OF NEEDLESTICK INJURY. THESE CONTAINERS ARE LOCATED THROUGHOUT THE HOSPITAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586173 ↗