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PowerPICC CK000928Recalls & reported problems

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

All models of PowerPICC (118)

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741188053), received between Jul 8, 2021 and Nov 24, 2021 — classified as 2 malfunctions.

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 16, 2026.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1
  • Material Frayed1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 24, 2021Material Frayed; Material Frayed

    IT WAS REPORTED "PICC WAS PLACED WITH NO TRACKING/3CG ISSUES. AFTER PLACEMENT THE NURSE TOOK THE WIRE OUT OF THE PICC TO EXAMINE INTEGRITY. WHEN THE WIRE WAS TAKEN OUT, THE TIP OF THE STYLET BROKE OFF. CLINICIAN FEELS AS IF THE INTEGRITY OF THE WIRE IS "OFF" AS IT DOESN'T HAVE THE TYPICAL BOUNCE THAT SHE WOULD NORMALLY SEE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12870010 ↗
  • MalfunctionJul 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED "CLINICIAN NOTED THAT A HUMAN HAIR COULD BE SEEN INSIDE A SEALED PICC CATHETER INSERTION KIT LOCATED IN STOCK ROOM." NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12139836 ↗

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

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Sources and updates

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