PowerPICC CK000633BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741143762), received between Sep 13, 2018 and Oct 31, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LINE SEEMS TO BE LEAKING. LOCATION: LEFT MID-THIGH FEMORAL LENGTH: 55CM. YES USED ON A PATIENT, NO HARM DONE. TREATED FOR A FIB. MEDICATIONS CARDIZEM, HEPARIN. LEAKING NOTED FROM LINE WHEN FLUSHING. STAT LOCK SECUREMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699907 ↗
• MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED: LINES SEEM TO BE LEAKING. BED WAS FOUND SATURATED AFTER INFUSION, LEAKING AT SITE. ADDITIONAL INFORMATION: LOCATION: RIGHT MID-THIGH. LENGTH: 50 CM. YES THIS WAS USED ON A PATIENT, NO HARM WAS DONE. TREATED FOR FEVER, N/V, COVID POSITIVE. STAT LOCK SECUREMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698569 ↗
• MalfunctionSep 13, 2018Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT CUSTOMER HAD A 5 FRENCH TRIPLE LUMEN PROVENA LEAKING AT THE EXTENSION LEG. IT WAS STATED THAT THERE WAS A HOLE IN THE CATHETER AT THE 3CM MARK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7873823 ↗