PowerPICC Provena CK000823Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741152603), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Infuse” (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.

• MalfunctionMar 3, 2023Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE LINE NOT DRAWING FAILED TROUBLESHOOTS, POSITIONAL. 2/6/2023 MULTIPLE DECLOTS REPORTED VAT (VASCULAR ACCESS TEAM) ASKED TO ASSESS PICC. CHANGED DRESSING NO KINKING NOTED UNDER DRESSING. BEDSIDE RN DID NOTE THAT THE LINE FLUSHES EASIER AND GETS BLOOD RETURN WHEN THE ARM IS ABDUCTED FROM THE BODY. (B)(6) 2023 PT WAS DIURESED AND ARM IS NO LONGER EDEMATOUS. LOOSE SKIN NOTED. REPORTS THAT THE PUMP ALARMS OCCLUSION WITH INFUSION AND THAT THE BLOOD RETURN IS NOT RELIABLE. PICC LINE WAS ASSESSED BY THIS RN. ALL LUMENS WITH BRISK BLOOD RETURN AND FLUSHES EASILY WHEN LINE WAS ASSESSED WITH PATIENT'S LEFT ARM IN DIFFERENT POSITIONS. IT APPEARS THAT WITH THE EDEMA RESOLVING AND THE STEEP INSERTION ANGLE IS THE CAUSE OF THE SHARP TURN SEEN ON THE X-RAY. NP REQUESTED THAT VAT PULL THE LINE BACK TO SEE IF THE TURN WOULD BE RESOLVED. LINE WAS PULLED BACK TO 7CM EXTERNAL FROM (FROM 5 CM). AFTER DRESSING WAS APPLIED AND ARM PLACED BACK IN A NEUTRAL POSITION, ALL LUMENS CONTINUE TO FLUSH EASILY WITH BRISK BLOOD RETURN. ADDITIONAL INFORMATION RECEIVED ON 2/28/2023: LINE WAS SECURED WITH SECURACATH. PATIENT LOST ACCESS ON 2/8. TREATMENT WAS MANAGED USING PIVS. O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479867 ↗