Peripheral Catheter Insertion Kit F218101Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741110665), received between Jun 1, 2017 and Apr 8, 2022 — classified as 1 injury, 4 malfunctions.

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

• InjuryApr 8, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED "AT APPROXIMATELY 10:30 AM TODAY, (B)(6) 2022, THERE WAS AN EQUIPMENT ISSUE WITH A MIDLINE DEVICE. MD ATTEMPTED TO INSERT A MIDLINE INTO PATIENT. THE DEVICE MALFUNCTIONED, DR CALLED SURGERY TO AID IN THE REMOVAL OF THE MIDLINE FROM PATIENT, WHICH WAS SUCCESSFUL. NO INJURY TO PATIENT; PATIENT DENIES PAIN; VA DUPLEX OF THE AFFECTED LIMB ORDERED. WE RECOVERED THE DEVICE."

  Patient problems: Foreign Body In Patient

  MAUDE report 14053568 ↗
• MalfunctionApr 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY PICC RN THAT THE CATHETER TIPS SPLIT AFTER INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977760 ↗
• MalfunctionApr 2, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED POWERGLIDE CATHETER WILL NOT PERFORATE THE PATIENTS SKIN. THE BEVEL WILL GO IN BUT OTHERWISE EVEN WITH LARGE AMOUNTS OF FORCE THE CATHETER WILL NOT THREAD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9917310 ↗
• MalfunctionJul 18, 2017Air Leak; Hole In Material; Split

  PER SALES REP, THE FACILITY REPORTED THAT THE MIDLINE IV CATHETER WAS REMOVED ON (B)(6) 2017 DUE TO CONCERN OF MALFUNCTION. NURSE REPORTED THAT THE LINE FLUSHED EASILY BUT WHEN TRYING TO ASPIRATE FOR BLOOD RETURN, AIR FILLED THE SYRINGE. THE CATHETER WAS REMOVED AND A SPLIT/HOLE WAS NOTED IN TUBING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6721709 ↗
• MalfunctionJun 1, 2017Physical Resistance; Material Integrity Problem; Noise, Audible

  PER CLINICAL SPECIALIST, THE FACILITY REPORTED THAT DURING PLACEMENT OF THE DEVICE, THE NEEDLE PIERCED AND WENT IN UNDER THE SKIN, BUT NOT INTO THE VESSEL. IT WAS STATED THAT AS THE NURSE WENT TO PUSH THE CATHETER IN, THERE WAS RESISTANCE, A POP WAS HEARD AND THE RN WENT TO PULL IT BACK AND THE GUIDEWIRE HAD BARBED. THE RN THEN UNCOILED IT AND THE WHOLE THING CAME OUT. HE STATED THAT THE INTERNAL WIRE HAD BEEN CUT WHEN THE NEEDLE ACCESSED THE SKIN AND THE WIRE MIGHT HAVE BEEN SLIGHTLY EXTENDED. THE NURSE CALLED THE PHYSICIAN WHO STATED THAT THEY DID NOT NEED TO DO AN X-RAY; THE NURSE HAD PALPATED AND COULDN¿T FEEL ANYTHING INSIDE THE PATIENT. A NEW CATHETER WAS PLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6605862 ↗