PowerPICC Provena S1173108Recalls & reported problems

Bard Access Systems, Inc. · 3 Fr Single Lumen · Class 2 · Implant

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

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741130106), received between Feb 6, 2018 and May 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak3
Break1
Component Missing1
Contamination /Decontamination Problem1

Patient problems

No Known Impact Or Consequence To Patient3
No Clinical Signs, Symptoms or Conditions1
Swelling1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 18, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT UPON OPENING BD 3FR PICC KIT HAD BLACK SPECKS ON THE BLUE WRAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25208049 ↗
MalfunctionApr 6, 2018Component Missing
IT WAS REPORTED THAT THE PATIENT CAME TO HAVE THEIR PICC REPLACED DUE TO THE PURPLE HUB AND CLAMP BEING MISSING FOR TWO DAYS. A BLUE OBJECT WAS INSERTED INTO THE OPEN END OF THE LINE AND TAPED IN PLACE. THE PICC IN HIS RIGHT ARM WAS ASSESSED AND INSERTIONS SITE WAS TENDER AND SWOLLEN BUT NO BLEEDING NOTED. UPON REMOVAL OF THE BLUE OBJECT AND TAPE, HEMOSTATS WERE PLACED ON THE OPEN END OF THE LINE AND THE PICC WAS REMOVED.
Patient problems: Swelling
MAUDE report 7403551 ↗
MalfunctionFeb 6, 2018Fluid/Blood Leak
THE FACILITY REPORTED THAT THE PICC WAS LEAKING AT THE HUB/PORT. THE CATHETER WAS REMOVED AND REPLACEMENT IN THE ED. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7246321 ↗
MalfunctionFeb 6, 2018Break; Fluid/Blood Leak
THE FACILITY REPORTED THAT THE PICC WAS PLACED IN THE IR ON (B)(6) 2017 AND WAS REPLACED ON (B)(6) 2018 DUE TO HUB BREAK/LEAKAGE. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7246318 ↗
MalfunctionFeb 6, 2018Fluid/Blood Leak
THE FACILITY REPORTED THAT THE CATHETER WAS REMOVED AND REPLACED IN THE ER DUE TO THE HUB ON THE PICC LEAKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7246313 ↗

Device details

UDI-DI	`00801741130106`
Brand	PowerPICC Provena
Model	S1173108
Company	Bard Access Systems, Inc.
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2021

Device type (GMDN): Peripherally-inserted central venous catheter

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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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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