PowerPICC Provena S3173335Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741129964), received between Dec 3, 2020 and Aug 26, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "ACCOUNT HAD A PICC WIRE UNRAVEL WHILE IN THE PATIENT. THEY WERE ABLE TO GET THE WIRE OUT. IT WAS NOT LEFT IN THE PATIENT." ON 08/11/2022 ADD INFO REC'D: CATHETER SECUREMENT WE USED A SINGLE SUTURE TO SECURE THE CATHETER. FLUORO GUIDANCE WAS UTILIZED AS ALWAYS FOR OUR PICC LINE PLACEMENTS. THE PATIENT DID NOT REQUIRE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303251 ↗
• MalfunctionDec 3, 2020Device Markings/Labelling Problem

  IT WAS REPORTED "THE PICC LINES COME MANUFACTURED WITH MARKINGS ON THE CATHETER. THE MARKINGS REPRESENT A CENTIMETER AND A NUMBER IS REPRESENTED EVERY 5TH MARKING (EX. 5, 10, 15 ETC). IT IS DOCUMENTED IN THE PATIENT¿S CHART THE LENGTH THE CATHETER IS MEASURED AND CUT. WE HAD TO OPEN AND USE TWO SEPARATE PICC LINE PACKAGES FOR THIS PATIENT BECAUSE THE MARKINGS WERE INACCURATE. ONE CATHETER HAD THE NUMBER 10 MARKED AFTER 12 CENTIMETER MARKS AND THE OTHER CATHETER HAD THE NUMBER 10 AFTER 11 MARKS. THIS DISCREPANCY MAKES IT DIFFICULT TO GET AN ACCURATE MEASUREMENT AND CAN RESULT IN OPENING AND USING MULTIPLE PICC CATHETER KITS PER PATIENT. ALSO, FOR REMOVAL PURPOSES THE LENGTH SHOULD BE ACCURATE AND CORRELATE WITH THE DOCUMENTED MEASUREMENT TO ENSURE NO PART OF THE CATHETER WAS RETAINED DURING REMOVAL." THIS REPORT ADDRESSES THE CATHETER THAT HAD THE NUMBER 10 MARKED AFTER 11 CENTIMETER MARK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10942951 ↗
• MalfunctionDec 3, 2020Device Markings/Labelling Problem

  IT WAS REPORTED "THE PICC LINES COME MANUFACTURED WITH MARKINGS ON THE CATHETER. THE MARKINGS REPRESENT A CENTIMETER AND A NUMBER IS REPRESENTED EVERY 5TH MARKING (EX. 5, 10, 15 ETC). IT IS DOCUMENTED IN THE PATIENT¿S CHART THE LENGTH THE CATHETER IS MEASURED AND CUT. WE HAD TO OPEN AND USE TWO SEPARATE PICC LINE PACKAGES FOR THIS PATIENT BECAUSE THE MARKINGS WERE INACCURATE. ONE CATHETER HAD THE NUMBER 10 MARKED AFTER 12 CENTIMETER MARKS AND THE OTHER CATHETER HAD THE NUMBER 10 AFTER 11 MARKS. THIS DISCREPANCY MAKES IT DIFFICULT TO GET AN ACCURATE MEASUREMENT AND CAN RESULT IN OPENING AND USING MULTIPLE PICC CATHETER KITS PER PATIENT. ALSO, FOR REMOVAL PURPOSES THE LENGTH SHOULD BE ACCURATE AND CORRELATE WITH THE DOCUMENTED MEASUREMENT TO ENSURE NO PART OF THE CATHETER WAS RETAINED DURING REMOVAL." THIS REPORT ADDRESSES THE CATHETER THAT HAD THE NUMBER 10 MARKED AFTER 12 CENTIMETER MARK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10942910 ↗