PowerPICC CK000187BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741101847), received between Feb 18, 2022 and Mar 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2022Separation Failure

  WHILE PLACING A PICC LINE, SINGLE LUMEN. PEEL AWAY SHEATH INTRODUCER THAT SHOULD BE EASILY PEELED AWAY, THE WINGS WOULD NOT SNAP OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13948895 ↗
• MalfunctionMar 25, 2022Defective Component; Defective Component

  IT WAS REPORTED VIA MEDWATCH "SETTING UP STERILE FIELD FOR PICC INSERTION IT WAS FOUND THAT THE LIDOCAINE AMPULE THAT IS IN THE SEALED PICC KITS WAS EMPTY, THE NECK OF THE AMPULE AS WELL AS THE PLASTIC SAFETY COVER WERE MISSING. DUE TO CONCERN ABOUT GLASS FRAGMENTS AND MISSING LIDOCAINE, ENTIRE KIT WAS THROWN AWAY AND A WHOLE NEW INSERTION KIT WAS OPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906139 ↗
• MalfunctionFeb 18, 2022Product Quality Problem; Component Missing

  SETTING UP STERILE FIELD FOR PICC INSERTION IT WAS FOUND THAT THE LIDOCAINE AMPULE THAT IS IN THE SEALED PICC KITS WAS EMPTY, THE NECK OF THE AMPULE AS WELL AS THE PLASTIC SAFETY COVER WERE MISSING. DUE TO CONCERN ABOUT GLASS FRAGMENTS AND MISSING LIDOCAINE, ENTIRE KIT WAS THROWN AWAY AND A WHOLE NEW INSERTION KIT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 13558886 ↗