Peripheral Catheter Insertion Kit ST118101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741139291), received between Jan 23, 2020 and Nov 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER, "WE HAVE A NURSE THAT PLACED A MIDLINE ON A PATIENT. SHE USED THE ST KIT, WITH THE INTRODUCER/WIRE. WHEN PLACING MIDLINE, SHE ACCESSED THE VEIN AND ADVANCED THE WIRE AS NORMAL. SHE PLACED THE MIDLINE/INTRODUCER COMBO ON THE END OF THE WIRE AND ADVANCED INTO PLACE APPROPRIATELY. SHE THEN WITHDREW THE WIRE, WHILE LEAVING THE INTRODUCER IN PLACE. THE EXTENSION TUBING WAS HOOKED UP TO THE END OF THE INTRODUCER AND THE MIDLINE WAS USED THIS WAY, WITH THE INTRODUCER IN PLACE. A FEW DAYS INTO THE DWELL TIME, A FLOOR NURSE NOTICED IT WAS FLUSHING SLUGGISHLY AND WAS HAVING DIFFICULTY WITH BLOOD DRAW. WHEN THE IV TEAM NURSE WENT TO ASSESS THE MIDLINE, SHE NOTED THE WHITE INTRODUCER PIECE WAS IN PLACE WITH THE EXTENSION HOOKED UP TO THE INTRODUCER. WHEN REMOVING MIDLINE, SHE ALSO NOTED THE INTRODUCER IN PLACE AT THE TIP." ADDITIONAL INFORMATION RECEIVED ON OCTOBER 21, 2024: IT WAS REPORTED DATE OF EVENT WAS 10/13/2024. MIDLINE WAS FLUSHING WITH RESISTANCE, SO LINE WAS PULLED. THE INTRODUCER WAS FOUND TO BE IN PLACE STILL. DUE TO PATIENT BEING DIFFICULT INTRAVENOUS ACCESS AND HAVING THE MIDLINE PULLED, PATIENT HAD A JUGULAR CENTRAL LINE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654692 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MIDLINE WAS PLACED(B)(6)2019 , WAS FOUND TO BE LEAKING ON 10/24/19. THE LINE WAS REPLACED ON 10/25/19. PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9624859 ↗