PowerPICC SOLO CK000394Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741091292), received between Jul 26, 2023 and Jul 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "ISSUE WITH ECG WIRE, CLEAR STYLET CONNECTION WITH BEIGE PORT LEAKING SALINE WHEN FLUSHED WHEN PICC LINE IN PATIENT AND ISSUES PULLING BACK BLOOD RETURN WHEN ECG WIRE IN PLACE THROUGH BEIGE STYLET SEEMS TO LET AIR IN. HAVE TO THEN DISCONNECT FLUSH AND EXPEL AIR AND RECONNECT IT AND PULL BACK TO ASSESS FOR BLOOD RETURN." ADDITIONAL INFO RECEIVED ON 13-JULY-23. CUSTOMER REPORTED THAT "THE PATIENT WAS IN ICU IN CENTRAL ACCESS. THEY HAD ISSUES WITH THE ECG WIRE BEING ALREADY BENT INSIDE THE NEW PICC, ALONG PLUNGER ON THE CLEAR ECG WIRE HOUSING SPRAYING OUT ONCE FLUSHES WHILE NEW PICC IN INTRODUCER WELL AS PULLING AIR AS THERE DOESN¿T SEEM TO BE A GOOD SEAL WITH THE CHANGE IN THE BEIGE PLUNGE. THE EVENT DELAYED THEM FROM BEING ABLE TO CORR BLOOD FROM RED LUMEN ONCE PICC WAS PLACED. THE WIRE BUMPING AS WE ARE PULLING IT IN AND OUT OF TRIM IT ETC. SLOW ME DOWN AS PATIENT WAS CRITICALLY ILL. SHE WAS ALSO IN RAPID AFIB REQUIRING A CXR TIP LOCATION SO THAT WAS ALSO A DELAY THAT COULDN¿T BE AVOIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17399042 ↗