Peripheral Catheter Insertion Kit F220101Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741110689), received between Jun 23, 2017 and Oct 16, 2019 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MS&S, "CALLER STATES SHE IS A NURSE AT A LONG TERM FACILITY THAT USES THE POWERGLIDE PRO. SHE STATES THEY HAVE BEEN EXPERIENCING SOME LEAKING AT THE INSERTION SITE WITH THESE DEVICES AFTER ROUGHLY FOUR DAYS OF USE. CALLER ASKING WHAT COULD BE CAUSES OF THIS ISSUE? CALLER PROVIDE LOT NUMBER RECW0442." MS&S DISCUSSED POSSIBLE CAUSES OF LEAKING AROUND MIDLINES: INFILTRATION, FIBRIN BUILD UP, THROMBUS, OCCLUSIONS, INFLAMMATION FROM VESICANTS/MEDICATIONS, IMPROPER FLUSHING ROUTINE, LOOSE CONNECTION, ETC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199794 ↗
• MalfunctionFeb 14, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT THE "CATHETER SHEARED". NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340922 ↗
• MalfunctionJun 14, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NURSE PLACED THE POWERGLIDE INTO THE PATIENT'S BASILIC VEIN AND THE GUIDEWIRE "DISLODGED FROM THE DEVICE INTO THE SKIN TISSUE." A NEW DEVICE WAS PLACED. AFTER THE 2ND DEVICE WAS PLACED SUCCESSFULLY, THE RN NOTICED THAT A PIECE OF THE GUIDEWIRE ON THE 1ST DEVICE WAS IN THE PATIENTS SKIN. SHE PULLED THE GUIDEWIRE OUT OF THE SKIN TISSUE, NO TESTING WAS DONE TO ENSURE ALL OF THE GUIDEWIRE WAS REMOVED FROM THE PATIENT." THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602369 ↗
• MalfunctionFeb 1, 2018Split

  THE FACILITY REPORTED TO THE SALES REP THAT DURING PLACEMENT OF THE CATHETER THE RN NOTED A SPLIT/SHEAR IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS REMOVED AND A NEW DEVICE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7234140 ↗
• MalfunctionDec 6, 2017Bent

  IT WAS REPORTED BY THE FACILITY THAT WHILE REMOVING THE HOUSING UNIT, IT WAS NOTED THAT THE CATHETER WAS BENT. THE DEVICE WAS REMOVED AND A NEW DEVICE USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT OTHER THAN REQUIRING TWO NEEDLE STICKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088162 ↗
• InjuryAug 31, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE SALES REP THAT THE NURSE INSERTED THE MIDLINE IN THE LEFT UPPER ARM OF THE PATIENT, THE PATIENT BEGAN COMPLAINING OF PAIN SO THE NURSE TRIED TO REMOVE THE DEVICE WITHOUT SUCCESS. A SECOND MEMBER OF THEIR TEAM ATTEMPTED TO REMOVE THE DEVICE WAS UNSUCCESSFUL. INTERVENTIONAL RADIOLOGY HAD TO REMOVE THE DEVICE. THE DEVICE WAS SUCCESSFULLY REMOVED AND SECURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Pain

  MAUDE report 6835060 ↗
• MalfunctionJun 27, 2017Fluid/Blood Leak

  PER SALES REP, THE FACILITY REPORTED THAT AFTER THE DEVICE WAS PLACED AND ASPIRATED, THE NURSE FLUSHED THE CATHETER. IT WAS STATED THAT SALINE SQUIRTED FROM THE HUB OF THE CATHETER (WHERE THE CATHETER MEETS THE PINK HUB) WHEN THE DEVICE WAS FLUSHED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6672350 ↗
• MalfunctionJun 23, 2017Break; Detachment Of Device Component

  PER SALES REP, THE FACILITY REPORTED THE NURSE TRIED TO THREAD WIRE AND THE CATHETER GOT CAUGHT UP ON THE NEEDLE AND SHEARED. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663771 ↗