Peripheral Catheter Insertion Kit ST120101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741139277), received between Nov 23, 2021 and Aug 26, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED, PATIENT SAID THEY ROLLED OVER AND FELT SOMETIME FROM THEIR MIDLINE. THE EXTENSION TUBING BROKE WHERE THE NEEDLE FREE CONNECTOR ATTACHES. NO PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065806 ↗
• MalfunctionNov 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A X2 20 GA ST KIT THAT HAVE THE INNER CANNULA KINKED AND UNABLE TO GUIDE OVER THE WIRE. IT WAS STATED A WHOLE NEW KIT WAS OPENED TO GET THE INNER CANNULA ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863279 ↗
• MalfunctionNov 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE RED PORT CRACKING AND LEAKING WITH THE DOUBLE LUMEN 4 FR PICC LINE. IT WAS STATED THEY HAD TO CHANGE OUT / REPLACE THE PICC LINE. ADD INFO RCVD 11/10/2021: I AM NOT ABLE TO RESEARCH ALL THAT INFO AT THIS TIME, ALL I CAN TELL YOU IS THE CATHETER WILL NOT GO IN OVER THE WIRE, LIKE ITS KINKED BUT WE DO NOT SEE A KINK. IF I GET MORE THEN I WILL REPORT FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862150 ↗