Peripheral Catheter Insertion Kit F118107TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741140464), received between Dec 17, 2019 and Oct 17, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2023Break; Break

  IT WAS REPORTED BY MEDWATCH THAT THE MIDLINE WAS CAUSING PATIENT PAIN, CARE TEAM DC'D (DISCONTINUED) MIDLINE. MIDLINE REMOVED AND THE CATHETER TIP WAS RETAINED IN THE PATIENT'S ARM. TUBULAR OPACITY IN THE RIGHT DISTAL ARM AS DETAILED LIKELY CORRELATING WITH RETAINED CATHETER FRAGMENT. OTHERWISE UNCHANGED APPEARANCE OF THE CHEST COMPARED TO PRIOR STUDY. NO OTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17949975 ↗
• InjuryNov 18, 2022Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER "POWERGLIDE PRO GUIDEWIRE BROKE IN PATIENT. NURSES STATES THEY WERE PLACING A POWERGLIDE PRO MIDLINE IN A PATIENT. WHEN THE NURSE WENT TO REMOVE THE GUIDEWIRE, SHE FELT LIKE THE TIP OF IT GOT CAUGHT ON THE SHEATH. ONCE SHE GOT THE GUIDEWIRE OUT, NURSE STATES IT LOOKS LIKE THE TIP HAS BROKEN OFF. NURSE IS ASKING WHAT TYPE OF IMAGING TO PERFORM TO SEE IF PART OF THE GUIDEWIRE IS STILL IN THE PATIENT. INFORMED NURSE THE GUIDEWIRE IS MADE OF NITINOL. IT WILL SHOW UP ON X-RAY, HOWEVER THEY SHOULD CONSIDER THE POSSIBILITY OF IT MIGRATING WHEN THEY SCAN IT. INFORMED NURSE SHE SHOULD DISCUSS WITH THE PROVIDER THE MATERIAL OF THE GUIDEWIRE AS WHICH IMAGINING TO ORDER WOULD BE A CLINICAL DECISION THE PROVIDER SHOULD MAKE."

  Patient problems: Foreign Body In Patient

  MAUDE report 15825967 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED "POWERGLIDE FELL APART. IT SEEMS TO BE MORE OF AN ISSUE WHEN PLACING IN MORE SUPERFICIAL VESSELS RATHER THAN DEEPER ONES. MOST LIKELY DUE TO THE ANGLE AND PRESSURE APPLIED WHEN ADVANCING (LEAP FROGGING) INTO THE VEIN. IT CAUSES IT TO SPLIT AND OPEN UP LIKE A SPACE SHUTTLE LAUNCHING TO THE MOON. PIECES FALLING OFF AND BREAKING APART THE FURTHER IT TRAVELS. MAY JUST BE OPERATOR ERROR. EXPERIENCED THE ISSUE WITH THE KIT. NO PATIENT HARM, JUST MAKES INSERTION DIFFICULT."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15736362 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED "POWERGLIDE IS FALLING APART. I USED ONE TODAY THAT GAVE ME THE ISSUE OF FALLING APART. THIS WAS ONE OF THE SINGLE CATHETERS , NOT WITHIN A KIT. IT SEEMS TO BE MORE OF AN ISSUE WHEN PLACING IN MORE SUPERFICIAL VESSELS RATHER THAN DEEPER ONES. MOST LIKELY DUE TO THE ANGLE AND PRESSURE APPLIED WHEN ADVANCING (LEAP FROGGING) INTO THE VEIN. IT CAUSES IT TO SPLIT AND OPEN UP LIKE A SPACE SHUTTLE LAUNCHING TO THE MOON. PIECES FALLING OFF AND BREAKING APART THE FURTHER IT TRAVELS. IT DOESN'T HAPPEN WITH THE CATHETERS IN THE KIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254749 ↗
• MalfunctionOct 14, 2021Activation Problem; Activation Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "THIS MORNING I WAS PLACING A MIDLINE. THERE WERE NO ISSUES WITH THE INSERTION ¿ IT WAS A BREEZE. I WAS NOT ROUGH WITH THE INSERTION. THE NEEDLE HOUSING PROTECTOR COMPLETELY DETACHED FROM THE DEVICE AND THE RED O-RING IN THE INSIDE IS RATTLING AROUND ALONG WITH SOME LITTLE WIRE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12633093 ↗
• MalfunctionAug 5, 2021Activation Problem; Activation Problem

  IT WAS REPORTED POWERGLIDE NEEDLE TIP WAS LEFT EXPOSED. NO PATIENT HARM REPORTED. ADDITIONAL INFO. RECEIVED 07/19/2021 " WHEN PLACING A 10CM POWERGLIDE MIDLINE, VENOUS ACCESS WAS OBTAINED, THE WIRE EASILY THREAD INTO VEIN, AND CATHETER EASILY SLID OVER GUIDEWIRE INTO PATIENT¿S VESSEL. HOWEVER, WHEN REMOVING [VERY GENTLY] THE REMAINDER OF THE CATHETER FROM THE GREEN WINGS, THE NEEDLE HOUSING DEVICE REMAINED CONNECTED TO THE GREEN WINGS AND DID NOT STAY ON THE NEEDLE; THEREFORE, THE NEEDLE TIP WAS LEFT EXPOSED AND WAS A HAZARD/SHARP. NO PATIENT HARM OCCURRED. LINE WAS SALVAGEABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281153 ↗
• MalfunctionJan 7, 2021Defective Component; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED "WE HAD A CATHETER MALFUNCTION.". ADD INFO RCVD 12/15/2020: NURSE WAS BEING TRAINED. ON SECOND ATTEMPT SHE WAS UNSUCCESSFUL. SHE PLACED THE NEEDLE ON THE TABLE AS IT WAS NOT DISENGAGED YET. THE TRAINER THEN DEMONSTRATED HOW TO DISENGAGE THE SAFETY MECHANISM WITH THE NEEDLE AT THE BEDSIDE AS SHE THE TRAINEE CONTINUED TO HOLD PRESSURE ON THE PATIENT. THE WIRE IS TYPICALLY LOCATED ON THE VERY END WHEN THE SAFETY MECHANISM IS ACTIVATED. THE WIRE WAS MISSING. THE TRAINER LOCATED THE WIRE IN THE BACK CHAMBER. THE TRAINER HAS SAVED BOTH CATHETERS USED AND YOU CAN SEE ON THE SECOND CATHETER IT IS COILED. PLACEMENT INFO: FIRST ATTEMPT IN BASILICA VEIN- UNSUCCESSFUL. 2ND CATHETER SAME PATIENT UNSUCCESSFUL THIS REPORT ADDRESSES THE FIRST UNSUCCESSFUL PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11132361 ↗
• MalfunctionJan 7, 2021Mechanical Problem; Use of Device Problem; Defective Component

  IT WAS REPORTED "WE HAD A CATHETER MALFUNCTION." ADD INFO RECEIVED 12/15/2020: NURSE WAS BEING TRAINED. ON SECOND ATTEMPT SHE WAS UNSUCCESSFUL. SHE PLACED THE NEEDLE ON THE TABLE AS IT WAS NOT DISENGAGED YET. THE TRAINER THEN DEMONSTRATED HOW TO DISENGAGE THE SAFETY MECHANISM WITH THE NEEDLE AT THE BEDSIDE AS SHE THE TRAINEE CONTINUED TO HOLD PRESSURE ON THE PATIENT. THE WIRE IS TYPICALLY LOCATED ON THE VERY END WHEN THE SAFETY MECHANISM IS ACTIVATED. THE WIRE WAS MISSING. THE TRAINER LOCATED THE WIRE IN THE BACK CHAMBER. THE TRAINER HAS SAVED BOTH CATHETERS USED AND YOU CAN SEE ON THE SECOND CATHETER IT IS COILED. PLACEMENT INFO: FIRST ATTEMPT IN BASILICA VEIN- UNSUCCESSFUL. 2ND CATHETER SAME PATIENT UNSUCCESSFUL. THIS REPORT ADDRESSES THE SECOND UNSUCCESSFUL PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11132355 ↗
• MalfunctionMar 19, 2020Material Frayed; Material Frayed

  IT WAS REPORTED DURING INSERTION RESISTANCE AND WAS UNCOMFORTABLE, RN ASKED FOR ASSISTANCE. WHEN RETRACTED THE, WIRE BROKE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857719 ↗
• MalfunctionDec 17, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE INSERTION FELT NORMAL UNTIL DEPLOYMENT OF CATHETER, RN NOTICED WIRE AND NEEDLE NOT CAPPING, REMOVED COMPLETE DEVICE. UNSUCCESSFULLY ATTEMPTED ANOTHER PLACEMENT IN PT. OTHER ARM. NO PATIENT HARM. REQUESTED FURTHER INFORMATION REGARDING UNSUCCESSFUL PLACEMENT. ON (B)(6) 2019- RN STATED, "THE FIRST PLACEMENT (WITH THE CATHETER WITH THE WIRE THAT MALFUNCTIONED) WAS IN THE PATIENT¿S LEFT BRACHIAL VEIN. THE SECOND ATTEMPT WAS IN THE PATIENT¿S RIGHT ARM BUT I WAS UNABLE TO GET ACCESS INTO THIS VEIN DUE TO PATIENT CONDITIONS (HYPOTENSION, 3-4+ PITTING EDEMA) AND NOT DUE TO ANOTHER DEVICE ISSUE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9477874 ↗