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PowerPICC Provena SOLO CK001031Recalls & reported problems

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

All models of PowerPICC Provena SOLO (19)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741223983), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED BY THE CUSTOMER THAT THEY OPENED A #4 FRENCH DUAL LUMEN PICC KIT THAT HAD A HAIR INSIDE THE KIT. ADD INFO RECEIVED ON (B)(6) 2023 THE EVENT WAS DISCOVERED WHEN CUSTOMER OPENED THE KIT, SHE SAW A LARGE BLACK HAIR INSIDE THE KIT. SHE DISCARDED THIS KIT, SO IT WAS NOT USED ON THE PATIENT. NO OTHER INFORMATION PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17490726 ↗

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

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

Sources and updates

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