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PowerPICC CK000795Recalls & 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
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 00801741144776), received between Jul 31, 2023 and Jul 31, 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 16, 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.

  • MalfunctionJul 31, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED BY CUSTOMER THAT ITEM WITHIN GAUZE IN STERILIZED PACKAGING. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH ON 08/22/2023: A BEDSIDE PICC WAS PLACED IN 2 LS (SITE NAME) YESTERDAY EVENING. AT THE END OF THE PROCEDURE THE APP (ADVANCED PRACTICE PROVIDER) WAS THROWING THE GAUZE AWAY AND SHE SAW A WEIRD DARK SPOT IN THE CENTER OF THE GAUZE PILE (PIC WAS SENT IN EMAIL TO IC, [REDACTED NAME] AND RISK MANAGEMENT). IT WAS MALODOUROUS AS WELL. I HAVE THE ACTUAL GAUZE IF THERE IS ANY INTEREST. AFTER DISCUSSING WITH HER SUPERVISING ATTENDINGS, A DECISION WAS MADE TO PULL THE PICC AND PLACE A NEW ONE ON THE OTHER SIDE. THE ICU TEAM AND NURSE MANAGER WERE MADE AWARE, AS WELL AS THE HCP. WE DO NOT USE ALL THE GAUZE SUPPLIED IN THE PACK DURING A PICC LINE (RELATED TO LOW EBL) SO WE ARE CONFIDENT THAT IT DIDN¿T COME IN TO CONTACT WITH ANYTHING. BUT, WE OF COURSE STILL HAVE CONCERNS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17424583 ↗

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Sources and updates

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