Peripheral Catheter Insertion Kit F118080Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741110504), received between Feb 23, 2017 and Dec 7, 2018 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Kinked” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2018Difficult to Insert; Retraction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE WIRE WAS THREADED, MET RESISTANCE WITH CATHETER DEPLOYMENT, FOLLOWING/DURING RETRACTION CATHETER SHEERED AND HAD TO BE RETRIEVED. ADDITIONAL EVENT INFORMATION RECEIVED FROM CONTACT AT FACILITY STATED, "ATTEMPTED TO START A MIDLINE IN THE LEFT UPPER ARM. I CONFIRMED PLACEMENT BY SEEING THE TIP OF THE MIDLINE IN THE MIDDLE OF THE VEIN. I INSERTED THE GUIDE WIRE AND THE INSERTION FELT ¿TOUGH¿ BUT IT INSERTED IN ALL OF THE WAY. I WENT TO THREAD THE CATHETER AND IT WOULDN¿T THREAD. I RETRACTED THE CATHETER BACK AND IT WOULDN¿T PULL BACK ALL OF THE WAY. THEN I RECOGNIZED THAT THE TIP OF THE CATHETER WAS STUCK INSIDE OF THE PATIENTS SKIN. I THEN HAD TO SEE IF THE GUIDE WIRE WOULD PULL BACK BECAUSE IT SHOULD HAVE BEEN RETRACTED SECOND TO THE ALREADY INSERTED CATHETER. THE GUIDE WIRE PULLED BACK BUT THE CATHETER WAS STILL STUCK. THE DOCTOR PRESENTED AT THE BESIDE AND DECIDED TO JUST PULL THE CATHETER APART. TAKING A LOOK AT THE CATHETER AFTER HE RETRIEVED IT, IT APPEARS THAT THE CATHETER WAS SHEARED SOMEHOW."

  Patient problems: No Information

  MAUDE report 8142199 ↗
• InjuryMay 24, 2018Break

  IT WAS REPORTED THAT WHEN THE MD ATTEMPTED TO REMOVE THE CATHETER AT BEDSIDE, A 2CM PIECE BROKE OFF. THE SEGMENT WAS NOT ABLE TO BE LOCATED, EVEN AFTER SURGICAL INTERVENTION.

  Patient problems: No Information

  MAUDE report 7541043 ↗
• InjuryMar 22, 2018Kinked; Difficult to Remove; Device Inoperable

  IT WAS REPORTED THAT THE POWERGLIDE PRO WAS PLACED IN THE PATIENT'S LEFT UPPER ARM. IT WAS STATED THAT INITIALLY THE DEVICE WAS FUNCTIONAL AND HAD BLOOD RETURN; BUT LATER THE SAME DAY IT BECAME NON-FUNCTIONAL AND THE RN'S WERE UNABLE TO REMOVE IT. X-RAY SHOWED THE CATHETER WAS KINKED INSIDE THE PATIENT'S ARM. VASCULAR SURGERY REMOVED MOST OF THE CATHETER, HOWEVER 2CM OF IT REMAINED IN ARM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7364209 ↗
• MalfunctionFeb 22, 2018Break

  THE FACILITY REPORTED TO THE SALES REP THAT THE CATHETER BROKE BY THE HUB. THE MIDLINE WAS PLACED IN THE RIGHT UPPER ARM WITH NO DIFFICULTY OR COMPLICATIONS. THE ORIGINAL NEEDLE OUT OF THE MIDLINE KIT WAS CONTAMINATED PRIOR TO INSERTION SO A SINGLE MIDLINE WAS DROPPED ON TO THE FIELD FOR THE INSERTION. PLACEMENT OCCURRED AROUND 1630. AROUND 2030 THE PATIENT PUT HIS CALL LIGHT ON COMPLAINING OF HIS RIGHT ARM BEING WET. THE NURSE FOUND BLOOD ON HIS ARM AND THE MIDLINE PULLED OUT LYING ON THE BED WITH ONLY APPROXIMATELY .5CM OF THE CATHETER CONNECTED TO THE HUB. THE REMAINING 7CM WAS UNABLE TO BE LOCATED AFTER "TURNING THE ROOM UPSIDE DOWN." THE PRACTITIONER ON CALL ORDERED MULTIPLE X-RAYS AND SCANS TO TRY TO LOCATE THE MIDLINE AND ALL SCANS RETURNED NEGATIVE FOR THE MISSING CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7290855 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF 8 CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #7.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848261 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF 8 CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848257 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF 8 CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #8.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848256 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF 8 CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #6.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848255 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF (B)(4) CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #3.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848252 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF 8 CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848251 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF (B)(4) CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848249 ↗
• MalfunctionSep 7, 2017Kinked; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE FACILITY HAS HAD A TOTAL OF (B)(4) CATHETERS NOT DEPLOY PROPERLY AND KINK BACK ON THEMSELVES UNDER ULTRASOUND, 180 DEGREES. THERE WAS NO PATIENT INJURY REPORTED, BUT A DELAY IN PATIENT CARE AS MULTIPLE ATTEMPTS WERE MADE. PATIENT #4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848248 ↗
• MalfunctionFeb 23, 2017Coiled; Device Operates Differently Than Expected

  ON 12/19/2016-PER SALES REPRESENTATIVE, THE FACILITY REPORTED THAT THE CATHETER WAS INSERTED INTO PATIENT WITHOUT ANY ISSUES; HOWEVER, ONCE THE HOUSING WAS REMOVED, CLINICIAN NOTICED THAT THE WIRE WAS NOT STICKING OUT OF THE SAFETY HOUSING. IT WAS STATED THAT THERE WAS CONCERN THAT THE WIRE HAD BEEN SHEARED IN THE PATIENT. ANOTHER CLINICIAN EXAMINED THE HOUSING AND REPORTEDLY REALIZED THAT THE WIRE WAS INTACT BUT WAS COILED UP WITHIN THE HOUSING. HE DISASSEMBLED THE DEVICE TO CONFIRM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6353221 ↗