PowerPICC Provena S9385108DRecalls & reported problems
Bard Access Systems, Inc. · DOT PPICC KR, 5F TL, Max w/TLS · Class 2 · Implant
All models of PowerPICC Provena (116)
Data updated Oct 18, 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 00801741112881), received between Feb 23, 2018 and Feb 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
Most reported problems
Device problems
- Break1
- Crack1
- Fluid/Blood Leak1
Patient problems
- Extravasation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2024Break; Break
IT WAS REPORTED BY CUSTOMER THAT THEY HAVE A TL PICC FROM STAFF THAT THE EXTERNAL PORTION OF THE PICC BROKE OFF BELOW THE HUB WHERE THE NEEDLELESS CONNECTOR ON THE POWER LUMEN. THE PICC WAS INSERTED ON (B)(6) AND REMOVED ON (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18767049 ↗MalfunctionFeb 23, 2018Crack; Fluid/Blood Leak
THE FACILITY REPORTED THAT THE LINE WAS FOUND TO BE LEAKING AND WAS REMOVED. IT WAS STATED THAT AFTER REMOVED A SUBCUTANEOUS CRACK IN THE TUBING WAS NOTED WHICH HAD CAUSED EXTRAVASATION.
Patient problems: Extravasation
MAUDE report 7294010 ↗
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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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