PowerPICC Provena CK000503ARecalls & reported problems

Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741140839), received between Jul 30, 2025 and Sep 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Defective Component2
Break1
Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER THAT THE RED HUB FELL OFF TLC PICC - PT BEING TURNED, SLIGHT TUG NOT EVEN ENOUGH TO PULL DRESSING UP AND HUB POPPED OFF. THIS WAS WITNESSED BY PICC FUSION RN. PATIENT HAD TO HAVE A NEW LINE PLACED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018293 ↗
MalfunctionJul 30, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE CLINICIAN REACHED OUT ABOUT AN ISSUE SHE'S HAVING WITH HER TRIPLES. SHE HAD A "STRETCHED POWER INJECTABLE LUMEN FOR THE SECOND TIME FROM DIFFERENT LOTS." THIS REPORT ADDRESSES THE FIRST OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667884 ↗
MalfunctionJul 30, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE CLINICIAN REACHED OUT ABOUT AN ISSUE SHE'S HAVING WITH HER TRIPLES. SHE HAD A "STRETCHED POWER INJECTABLE LUMEN FOR THE SECOND TIME FROM DIFFERENT LOTS." THIS REPORT ADDRESSES THE SECOND OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667883 ↗

Device details

UDI-DI	`00801741140839`
Brand	PowerPICC Provena
Model	CK000503A
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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