PowerPICC Provena S1294108Recalls & reported problems
Bard Access Systems, Inc. · 4 Fr Dual Lumen · Class 2 · Implant
All models of PowerPICC Provena (116)
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 00801741130137), received between Sep 6, 2023 and Sep 6, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- 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 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT ONE OF THE PICC LUMENS HAD A LEAK. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: IT WAS REPORTED BY THE CUSTOMER ¿THERE WAS A CRACK IN THE PROXIMAL END OF THE PURPLE LUMEN. TAPE WAS OVER THIS AREA, AND WHEN TAPE WAS REMOVED TO CHANGE THE DRESSING, BLOOD STARTED COMING OUT OF THE CRACK IN THE LUMEN. THERE WAS NO LEAKAGE NOTED PRIOR TO THIS. PATIENT HAS PERFORATED DIVERTICULUM. HE WAS ON TPN. PICC PLACED ON 8/8 AND LEAKED ON 8/16 SECURED WITH STATLOCK AND SORBAVIEW DRESSING. TPN WAS STOPPED FOR ABOUT 4 HOURS WHILE PICC WAS REPLACED. THERE WAS NO HARM TO THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695376 ↗
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- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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