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PowerPICC Provena CK000869Recalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant

All models of PowerPICC Provena (116)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741163296), received between Nov 6, 2019 and Jun 10, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 16, 2026.

Most reported problems

Device problems

  • Material Deformation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJun 10, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT THE PICC KINKED. THE PICC WAS PLACED IN THE LEFT ARM. IT WAS STATED THAT THE PATIENT HAD A LARGER ARM. ADD INFO RCVD 05/24/2021: WAS THERE PATIENT HARM REPORTED?: NO.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11980050 ↗
  • MalfunctionJun 9, 2021Material Deformation; Material Deformation

    IT WAS REPORTED KINKING IN PICC LINE. PICC WAS PLACED IN THE LEFT ARM. NO OTHER INFORMATION PROVIDED. ADD INFO RECEIVED 05/24/2021: DATE OF OCCURRENCE: (B)(6) 2021 WAS THERE PATIENT HARM REPORTED?: NO.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11971290 ↗
  • MalfunctionNov 6, 2019Material Deformation; Material Deformation

    IT WAS REPORTED THAT WHEN THE RN WAS PLACING A PICC SHE HAD TROUBLE WITH ONE OF THE LONGER (10CM) INTRODUCERS. IT WAS STATED THE INNER CANNULA CAME LOOSE AS THE RN WAS ATTEMPTING TO SLIDE OVER THE WIRE AND INTO THE VEIN. THE RN DIDN'T REALIZE IT HAD DONE THIS UNTIL IT WOULD NOT PUSH IN AND SHE SAW THAT THE OUTER PART HAD STARTED TO PUSH AGAINST THE SKIN WITHOUT THE RIGID INNER PART, CAUSING IT TO START TO TEAR AND PUSH UP. RN HAD TO GET A NEW INTRODUCER TO FINISH.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9285376 ↗

Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices

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Sources and updates

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