PowerPICC Provena CK000738Recalls & 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 00801741139512), received between Feb 8, 2019 and Aug 12, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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.

Most reported problems

Device problems

Contamination /Decontamination Problem4
Material Twisted/Bent2

Patient problems

No Clinical Signs, Symptoms or Conditions4
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionAug 12, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED "A LOT OF HAIR IS IN THE KIT." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315729 ↗
MalfunctionApr 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED "TODAY STAFF FOUND A LONG BLACK HAIR WHEN THEY OPENED TRIPLE LUMEN KIT. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11718627 ↗
MalfunctionApr 23, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED "STAFF FOUND A SMALL PLASTIC PIECE BROKEN OFF IN A 5FR TRIPLE LUMEN KIT WHEN THEY OPENED IT THIS PAST WEEKEND. THEY THREW THE KIT AWAY BUT THEY SAVED THE PLASTIC PIECE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11718468 ↗
MalfunctionNov 19, 2020Material Twisted/Bent
IT WAS REPORTED THAT THE PICC WAS KINKED. IT WAS STATED PICC WAS PLACED IN PATIENT USING 3CG TECHNOLOGY. ALL LUMENS DREW BLOOD. THE TEAM WAS CONSULTED 2 HOURS AFTER PLACEMENT STATING THAT ONLY 1 LUMEN WAS ABLE TO DRAW BLOOD. XRAY WAS ORDERED AND LINE PLACEMENT WAS CONFIRMED TO BE IN THE CORRECT LOCATION. ONLY 1 LUMEN FROM LINE WAS ABLE TO DRAW BLOOD DESPITE LINE BEING PLACED IN PROPER LOCATION. LINE WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10872045 ↗
MalfunctionNov 19, 2020Material Twisted/Bent
IT WAS REPORTED THAT THE PICC LINE KINKED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10872012 ↗
MalfunctionFeb 8, 2019Contamination /Decontamination Problem
IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE AN UNOPENED PICC TRAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8323208 ↗

Device details

UDI-DI	`00801741139512`
Brand	PowerPICC Provena
Model	CK000738
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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