Peripheral Catheter Insertion Kit ST020101DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741139376), received between Jan 30, 2020 and Mar 4, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionMar 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE POWERGLIDE LEAKED AT EXTENSION. THE CLINICIAN TOOK OFF EXTENSION AND PUT ON A DIFFERENT EXTENSION, LEFT FOR AN HOUR AND CAME BACK TO THE BED AND IT WAS LEAKING. TOOK OFF EXTENSION AND NO CRACK IN EXTENSION OR HUB THAT WAS NOTICED. THE CLINICIAN SAID THAT IT LOOKS LIKE THERE IS A DENT IN THE HUB OF CATHETER. CHANGED POWERGLIDE OVER WIRE. CHANGED EXTENSION AND NO ISSUES OR LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789084 ↗
• MalfunctionFeb 7, 2020Break; Break

  IT WAS REPORTED THAT MIDLINE PLACED AND PATIENT DISCHARGED TO HOMECARE. PATIENT RETURNED TO THE ED WITH MIDLINE BROKEN OFF AND MISSING HUB. APPROXIMATELY 2CM OF CATHETER OUT OF THE SKIN. MIDLINE REMOVED WITH TIP INTACT, MEASURED 8CM. THIS WAS A 10CM CATHETER AT INSERTION. NURSE SPOKE WITH HOMECARE RN WHO STATED "IT LOOKED KINKED AT A 90 DEGREE ANGLE AND WHEN SHE TOOK THE DRESSING OFF THE HUB WAS NOT ATTACHED, "THE LINE WAS SEVERED". PATIENT WAS ALERT AND ORIENTED WHEN BEING ADMITTED TO THE ED. CATHETER WAS REMOVED WITH NO ISSUES. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9681646 ↗
• MalfunctionJan 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POWERGLIDE WAS INSERTED ON (B)(6) 2019 IN AC OF COMBATIVE PATIENT. RN FLUSHED CATHETER ON (B)(6) 2019 AND NOTICED PINHOLE IN EXPOSED PART OF CATHETER. BODILY FLUID SPRAYED IN FACE OF RN UPON FLUSHING. RN UNDERWENT TESTING TO ELIMINATE RISK OF TRANSMISSION. THE CATHETER WAS REMOVED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 9650088 ↗