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PowerPICC SOLO Provena CK000868BRecalls & reported problems

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

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741231704), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Material Frayed” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Frayed1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • InjuryDec 18, 2025Material Frayed; Material Frayed

    IT WAS REPORTED, CLINICIAN WAS PLACING A PICC AS NORMAL. HE WAS IN THE VEIN AND INSERTED WIRE AND MET RESISTANCE IN THE SHOULDER AND STARTED TO RETRACT THE WIRE BACK. HE MET RESISTANCE LIKE THE WIRE SNAGGED. PULLED THE NEEDLE OUT AND STARTED TO PULL THE WIRE AND STILL MET RESISTANCE. THE OUTSIDE COIL OF THE WIRE, OUTER WINDING OF THE WIRE CAME OUT, BUT REALIZED THAT THERE WAS STILL WIRE IN THE PATIENT. HE LEFT THE TORNIQUET ON AN APPLIED PRESSURE WHERE THE WIRE WAS. FELT LIKE THE WIRE SNAGGED ON THE BEVEL. THE PATIENT WAS RESTLESS AND MOVING. THE VEIN HALF A CENTIMETER DEEP. 42% CVR. 4FRDL. PATIENT GOT CHEST X-RAY AND CONFIRMED WIRE WAS IN THE VEIN AND LOOKED THROUGH ULTRASOUND. PATIENT GOT INTO SURGERY AND THE WIRE LOGGED ITSELF INTO THE TISSUE. THE DOCTOR RETRIEVED WIRE. NURSE PULLED (B)(4) KITS OF THAT LOT # AND SET THEM ASIDE. PATIENT WAS 39 YEARS OLD WITH PNEUMONIA. WHITE COUNT OVER 50,000. HE WAS IN THE ICU. ACUTE ONSET CHF.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 23838284 ↗

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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