PowerPICC Provena S1385108D1Recalls & 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: 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 00801741154768), received between Jan 29, 2021 and Jan 28, 2023 — classified as 4 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 16, 2026.

Most reported problems

Device problems

Fluid/Blood Leak3
Break1
Defective Component1
Leak/Splash1

Patient problems

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

Recent adverse event reports

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

MalfunctionJan 28, 2023Break; Break
IT WAS REPORTED BY THE CUSTOMER "GREY LUMEN BROKE OFF AT TUBING." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261221 ↗
MalfunctionDec 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "WHEN FLUSHING Y PORT STOPPER SEEMED TO BE BULGING OFF/LEAKING." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15950159 ↗
MalfunctionDec 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED CUSTOMER NOTICED STYLET/RUBBER STOPPER BULGED WHEN FLUSHING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15950153 ↗
MalfunctionJan 29, 2021Fluid/Blood Leak; Fluid/Blood Leak; Leak/Splash; Defective Component
IT WAS REPORTED "ONE OF MY PICC RNS DISCOVERED THAT A T-SET THAT IS PART OF OUR PICC TRAY WAS DEFECTIVE AND HAD A LEAK BETWEEN THE PLASTIC TUBING AND THE HARD PLASTIC T. CAME FROM POWERPICC PROVENA REF#S1385108D1. LOT#REEW2971. EX 2021-11-30. " ADD INFO RECEIVED 01/11/2021: VASCULAR ACCESS RN PLACED DL POWERPICC PROVENA REF#S1385108D1 LOT#REEW2971 IN PATIENT AND NOTICED THERE WAS LEAKING COMING FROM THE T SET TUBING. PICC WAS PLACED WITH DIFFICULTY. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: STATLOCK. WAS THERE PATIENT HARM REPORTED?: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11251673 ↗

Device details

UDI-DI	`00801741154768`
Brand	PowerPICC Provena
Model	S1385108D1
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 13, 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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