PowerPICC Provena S1274118Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741130243), received between Mar 23, 2018 and Apr 20, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2018Fracture; Nonstandard Device

  IT WAS REPORTED THAT THE PICC WAS PLACED IN (B)(6) 2018. WHEN THE NURSE WAS CHECKING TO SEE IF THE LINE WAS STILL OPEN AND FUNCTIONING, THE PICC LINE FRACTURED EXTERNALLY 1 CM BELOW THE HUB ON THE PURPLE PART OF THE LUMEN. A NEW DEVICE WAS PLACED IN VIR. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448174 ↗
• MalfunctionMar 23, 2018Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED AT THE HUB. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7366692 ↗