PowerPICC Provena S9173108DRecalls & reported problems
Bard Access Systems, Inc. · 3 Fr Single 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 00801741130427), received between Aug 18, 2017 and Aug 18, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning 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 18, 2026.
Most reported problems
Device problems
- Positioning Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2017Positioning Problem
IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT THEY USED A 3 FR PROVENA CATHETER ON (B)(6) 2017, THE NURSE STATED THAT SHE DID NOT BELIEVE THAT THE CATHETER HAD ENOUGH "BODY" TO IT TO EASILY DROP INTO THE SVC. SHE STATED SHE STRUGGLED FOR NEARLY TWENTY MINUTES TO DROP WHAT SHOULD HAVE BEEN A VERY EASY PICC ON A (B)(6). SHE STATED THE SHERLOCK WENT "WILD" TURNING UP AND DOWN AND THEN UP AND DOWN AGAIN, FINALLY RESTING WITH THE "POPSICLE" UP AND LOOKING LIKE THE CATHETER WAS COMING FROM MID CHEST. AFTER GETTING AN X-RAY, SHE FOUND THAT SHE HAD CANNULATED THE AZYGOUS VEIN, WHICH SHE STATED IS NOT VERY EASY TO DO.
Patient problems: No Information
MAUDE report 6803817 ↗
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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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