Peripheral Catheter Insertion Kit F122080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741110542), received between Mar 23, 2017 and May 20, 2022 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Break; Break

  IT WAS REPORTED VIA MEDWATCH "DURING PLACEMENT OF AN ULTRASOUND-GUIDED IV, GUIDEWIRE AND CATHETER REPORTEDLY DEPLOYED WITHOUT RESISTANCE. DURING WIRE RETRACTION, ISSUE NOTED WITH THE DEVICE HANDLE LEADING TO DESTABILIZATION OF THE GUIDEWIRE AND CATHETER HUB. THE PLASTIC CATHETER DETACHED FROM THE CATHETER HUB AND WAS RETAINED IN PATIENT'S ARM."

  Patient problems: Foreign Body In Patient

  MAUDE report 14461862 ↗
• MalfunctionJul 16, 2021Break; Break

  IT WAS REPORTED "PT HAVING MIDLINE PLACED IN PICC SUITE BY EXPERIENCED IV RN WITH ASSIST RN ASSIST. CATHETER, NEEDLE AND WIRE STUCK ( POWERGLIDE PRO MIDLINE CATHETER 22G 8CM LOT#REEW4254) UNABLE TO BE RETRACTED FROM PT'S VESSEL, AND CATHETER BREAKING FROM HUB. ASSIST RN ACTIVATED RRT WHILE PROCEDURE RN PLACED A CLAMP ON CATHETER TO PREVENT MIGRATION. RRT REQUESTED TOURNIQUET REMAIN ON ARM, CATHETER BE HELD WITH CLAMPS AND PROVIDER BE NOTIFIED AND REQUEST FOR VASCULAR SURGERY CONSULT STAT TO BEDSIDE. ARM X-RAY COMPLETED TO ASSESS FOR CATHETER INTEGRITY VS MIGRATION. PT REASSURED OF SAFETY BY IV AND RRT RNS. WARM BLANKET APPLIED TO LEFT FOREARM IN EVENT THAT VESSEL SPASM MAY HAVE CONTRIBUTED TO INABILITY TO RETRACT CATHETER/WIRE. PROVIDER ( DR.) CAME TO BEDSIDE AND VASCULAR SURGERY TEAM INITIALLY REQUESTED THIS BE COMPLETED BY IR, HOWEVER BOTH IR PROVIDERS ARE IN PROCEDURES WITH ESTIMATED LENGTH OF TIME TO COMPLETION > 30 MIN. VASCULAR SURGERY CALLED AGAIN BY DR. AND THEY CAME TO BEDSIDE TO ASSIST. DR. DID REMOVE THE CATHETER INTACT FROM PT.'S VESSEL. IT DID COME APART AT THE HUB, BUT THE CATHETER WAS REMOVED INTACT OTHERWISE. GUIDEWIRE AND NEEDLE ALSO APPEAR TO BE INTACT. FURTHER OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12184285 ↗
• MalfunctionApr 19, 2019Entrapment of Device

  THE PICC NURSE AT THE FACILITY REPORTED, "PLACING A 22 G POWER GLIDE MIDLINE LOT NUMBER RECX2080 WHEN THE DEVICE FAILED. I ADVANCED THE GUIDE WIRE AND WHEN ATTEMPTING TO ADVANCE THE ¿WINGS¿ I COULD FEEL A METAL ON METAL GRINDING SENSATIONS IN MY FINGER TIPS. AT THIS POINT I ATTEMPTED TO WITHDRAW THE ENTIRE SYSTEM. IT FELT LIKE JUST THE ¿BODY¿ WITHDREW HOWEVER, AND WHEN I LOOKED DOWN AT THE TIP THERE WAS NO NEEDLE ONLY THE GUIDE WIRE. THE NEEDLE AND SAFETY LOCK DEVICE WERE STILL EMBEDDED WITH THE CATHETER IN THE SKIN. I WAS ABLE TO SUCCESSFULLY GET THE NEEDLE OUT OF THE CATHETER, HOWEVER AT THIS POINT I HAD BLOODY 8CM NEEDLE ."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533664 ↗
• InjuryOct 25, 2018Break; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NEEDLE WAS ADVANCED INTO VEIN WITH ULTRASOUND GUIDANCE. WIRE ADVANCED WITHOUT DIFFICULTY, AND THEN CATHETER ADVANCED WITHOUT DIFFICULTY. ONCE CATHETER FULLY ADVANCED TO SKIN, USER ALLEGEDLY NOTED DIFFICULTY REMOVING CASING FROM THE BACK OF THE DEVICE. REPORTEDLY, RESISTANCE WAS MET UPON RETRACTION, SO ATTEMPTED TO RETRACT HOUSING WITH CATHETER AS ONE UNIT. USER WAS APPARENTLY ABLE TO REMOVE THE HOUSING, BUT NOTICED THAT CATHETER HAD ALLEGEDLY SHEARED COMPLETELY IN HALF, CLOSE TO THE HUB OF THE CATHETER. TOURNIQUET WAS IMMEDIATELY APPLIED TO ARM, AND PHYSICIAN NOTIFIED. UPON FURTHER INSPECTION, NOTED THAT REMAINING CATHETER COULD BE OBSERVED IN SUBCUTANEOUS TISSUE, AND WAS REMOVED. ONCE REMOVED, CATHETER ALLEGEDLY LOOKED VISIBLY DAMAGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8005035 ↗
• InjuryMar 23, 2017Kinked; Difficult to Remove

  THE FACILITY REPORTED "UPON DISENGAGEMENT OF THE POWERGLIDE PRO MIDLINE, IV TEAM RN WAS UNABLE TO REMOVE THE GUIDEWIRE FROM THE PATIENT'S RIGHT ARM. ENTIRE CATHETER WAS LEFT IN THE PATIENT'S ARM, COVERED WITH STERILE 4X4 AND WRAPPED LIGHTLY WITH COFLEX TO ENSURE NO MOVEMENT OF THE CATHETER. PHYSICIAN WAS NOTIFIED AND THE PATIENT WAS TAKEN TO IR FOR REMOVAL. FLUOROSCOPIC IMAGE SHOWED A CRUMPLED CATHETER IN THE RIGHT ARM". ON EXAM THE PHYSICIAN NOTED THE NEEDLE PARTLY OUT AND THE OUTER PLASTIC CANNULA CRUMPLED AND MOSTLY INSIDE THE SKIN. DEVICE WAS REMOVED INTACT, NO RETAINED PIECES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6428215 ↗