PowerPICC Provena S1173108D2Recalls & 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: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741154829), received between Nov 19, 2024 and Jun 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (5 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

Activation Problem5
Material Deformation1

Patient problems

No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 23, 2025Activation Problem; Activation Problem
IT WAS REPORTED THE GREEN SAFETY PIECE ON NEEDLE INSIDE PICC KIT FELL OFF THE END OF THE NEEDLE WHEN RN TRIED TO SAFETY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310201 ↗
MalfunctionFeb 12, 2025Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THAT INTRODUCER NEEDLE DID NOT SAFETY AFTER PICC INSERTION PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370818 ↗
MalfunctionJan 13, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THEY HAD A DAMAGED INTRODUCER IN A PICC KIT AND WERE UNABLE TO USE. THE END OF THE PEEL AWAY SHEATH, WHERE THE GRAY AND WHITE MEET, IS DAMAGED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21139739 ↗
MalfunctionJan 13, 2025Activation Problem; Activation Problem
IT WAS REPORTED ACCESS NEEDLE DID NOT SAFETY FULLY AFTER USE, EXPOSING NEEDLE TIP TO CLINICIANS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21138941 ↗
MalfunctionDec 29, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER THE INTRODUCER NEEDLE SAFETY FAILED, AND THE NEEDLE DID NOT SAFETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032767 ↗
MalfunctionNov 19, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THE NEEDLE DID NOT SAFETY, IT WASN¿T NOTICED UNTIL THE SAFETY WAS ATTEMPTED. NO IMPACT TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20726724 ↗

Device details

UDI-DI	`00801741154829`
Brand	PowerPICC Provena
Model	S1173108D2
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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