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PowerPICC SOLO Catheter 3195335Recalls & reported problems

Bard Access Systems, Inc. · PowerPICC, Solo, · Class 2 · Implant

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 00801741027802), received between Sep 29, 2022 and Sep 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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

  • Defective Component1
  • Fluid/Blood Leak1

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.

  • MalfunctionSep 29, 2022Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

    IT WAS REPORTED THAT THE POWERPICC SOLO CATHETER WAS PLACED AROUND TWO WEEKS BEFORE THE EVENT OCCURRED (31/8). THE CATHETER WAS FOUND LEAKAGE FROM THE HUB WHEN THE NEEDLESS CONNECTOR WAS REMOVED. IT WAS ONLY USED FOR DRUG INFUSION BY PUMP AND COULD BE FUNCTIONED PROPERLY WHEN THE NEEDLESS CONNECTOR WAS ON. IT WAS REMOVED AT THE END OF TREATMENT (9/9). PATIENT STATUS/ INTERVENTION: NO INTERVENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15506463 ↗

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Sources and updates

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