PowerPICC Provena S1385108Recalls & reported problems

Bard Access Systems, Inc. · DOT PPICC KR, 5F TL, Full w/3CG · Class 2 · Implant

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741112713), received between Jul 11, 2019 and Sep 6, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination 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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Contamination /Decontamination Problem1
Defective Component1
Detachment of Device or Device Component1
Material Deformation1
Migration or Expulsion of Device1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 6, 2024Defective Component; Defective Component
IT WAS REPORTED BY THE CUSTOMER THAT OUTPATIENT CAME IN WITH THE CLAMP BROKEN OFF OF THE RED LUMEN. NO HARM TO PATIENT OR HEALTHCARE PROFESSIONAL. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163385 ↗
MalfunctionMay 14, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT SOME MECHANICAL OCCLUSIONS ARE HAPPENING DUE TO KINKING OF THE LINES, PRIMARILY ON 4F DL AND 5F TL LINES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11826717 ↗
MalfunctionMay 12, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED FACILITY FOUND A LONG BLACK HAIR ON TOP OF PICC KIT DRAPE. KIT # REDZ0654. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10050009 ↗
MalfunctionJul 11, 2019Migration or Expulsion of Device; Detachment of Device or Device Component
IT WAS REPORTED THAT PATIENT WAS IN ALCOHOL DETOX AND PULLED ON THE CENTER LUMEN OF PICC WITH INTENTION OF PULLING THE LINE OUT. IT WAS STATED THE PATIENT SUCCESSFULLY PULLED OFF THE CENTER LUMEN BUT DID NOT DISLODGE THE DRESSING OR STATLOCK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8782724 ↗

Device details

UDI-DI	`00801741112713`
Brand	PowerPICC Provena
Model	S1385108
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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All Catheter,intravascular,therapeutic,long-term greater than 30 days devices →

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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