PowerPICC SOLO CK000451Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741104183), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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 16, 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.

• MalfunctionFeb 23, 2021Activation Problem; Activation Problem; Fail-Safe Did Not Operate

  IT WAS REPORTED "SAFETY NEEDLE DID NOT SAFETY. SAFETY COVER CAME OFF THE NEEDLE AND SHARP WAS STILL EXPOSED." ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: ACCESS NEEDLE DID NOT SAFETY WHEN REMOVED FORM PATIENT AND NEEDLE WAS SUPPOSED TO BE PROTECTED WITH THE SAFETY CROWN. THE SAFETY CROWN CAME RIGHT OFF AND DID NOT HAVE A STOPPING POINT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: PLACEMENT INFO: THE INCIDENT OCCURRED DURING A USUAL AND STANDARD PICC INSERTION WITH A COOPERATIVE PATIENT. AFTER USE OF THE ACCESS NEEDLE, THE NEEDLE WAS REMOVED FROM THE PATIENT AS IS USUAL OVER THE WIRE AND WITHOUT DIFFICULTY. THE NEEDLE WAS THEN ATTEMPTED TO BE PLACED IN THE SAFETY POSITION. DURING THIS USUAL STEP, THE SAFETY CROWN DID NOT ENGAGE AND SLID COMPLETELY OFF THE NEEDLE WITHOUT STOPPING. THERE WAS NO RESISTANCE OR CATCH NOTED, JUST A SMOOTH REMOVAL OF CROWN AND MY MOVEMENT TO ENGAGE WAS NOT FORCEFUL IN ANY WAY. THE NEEDLE WAS PLACED IN A SMALL HOLE IN THE PICC TRAY FOR MY SAFETY DURING THE REST OF THE PROCEDURE. UPON PROCEDURE COMPLETION, THE NEEDLE HOUSING WAS LOCATED AND THE NEEDLE CAREFULLY RE-CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11369307 ↗