Monoject 8881225315Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521013438), received between Dec 23, 2021 and Jan 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 14, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE SLIDE WOULD FALL APART WHEN PUSHED. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER STATED WHEN THE PACKAGE WAS OPENED, THE "BUTTERFLY" FELL APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259212 ↗
• MalfunctionJan 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PRODUCT HAS BEEN HARD TO REMOVE FROM THE PATIENT. THIS HAS CAUSED 2 KNOWN NEEDLE STICKS THUS FAR. PER ADDITIONAL INFORMATION RECEIVED, WHEN THE STAFF MEMBER PUT THE BUTTERFLY IN THE PATIENTS ARM AND PULLED BACK AFTER THE COLLECTION, THE NEEDLE PART STAYED IN THEIR ARM. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED ON THE 2ND NEEDLE STICK INCIDENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259211 ↗
• MalfunctionDec 23, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE BLOOD COLLECTION SETS HAVE BEEN REJECTED BY THEIR CLINICAL STAFF, AS THEY ARE VERY FLIMSY, AND THE STAFF CANNOT HANDLE THEM SAFETY. PER CUSTOMER, A STAFF MEMBER WAS PIERCED BY A NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT TWO AREAS ARE UNSAFE, THE WINGS ARE NOT STURDY ENOUGH FOR SAFE USE AND THE SAFETY SHIELD. PER CUSTOMER, THE SAFETY SHIELD WAS ACTIVATED IN ONE INSTANCE, BUT THE SAFETY FAILED, AND THE NEEDLE WAS UNSHIELDED CAUSING A NEEDLE STICK TO THE HAND OF THE STAFF MEMBER DURING A PATIENT BLOOD DRAW. THE CUSTOMER FURTHER STATED THAT THERE WAS NO NEEDLE BREAK OR DETACH DURING USE. THE CUSTOMER FURTHER PROVIDED ADDITIONAL INFORMATION AND IT WAS STATED THAT THE NEEDLE STICK INJURY OCCURRED AFTER USE. THE PROCEDURE PERFORMED WAS VENIPUNCTURE AND THE EMPLOYEE WAS STUCK WHILE TRYING TO ENGAGE THE SAFETY DEVICE. PER CUSTOMER, AS A MEDICAL INTERVENTION EMPLOYEE STICK PROTOCOL TESTING WAS PERFORMED. THE CUSTOMER DOESN'T KNOW IF BLOOD TESTS WERE CONDUCTED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13082783 ↗