PowerPICC EtOH 1385108ERecalls & reported problems
Bard Access Systems, Inc. · PowerPICC EtOH 3CG 5 F Triple Lumen Nursing Full Tray · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741128387), received between Apr 14, 2020 and Apr 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED RUE PICC PLACED IN RIGHT BRACHIAL (B)(6) 2019. PAT PRESENTED TODAY FOR PICC EXCHANGE. SHE REPORTED EPISODIC PAIN JUST ABOVE INSERTION SITE REPORTING ONLY WITH RAPID INFUSIONS AND FAST FLUSHES OF SALINE. PATIENT STATED THIS STARTED AROUND THE FIRST WEEK OF MARCH. PATIENT PRESENTED WITH A VERY CLEAN HEALTHY APPEARING LINE AND NO SYMPTOMS OF A DVT. PATIENT STATES A FEW WEEKS AGO HER ARM SWELLED UP AND SHE NOTICED LEAKING AT THE INSERTION SITE DURING A RAPID HYDRATION TREATMENT THAT RESOLVED IN A COUPLE DAYS. PICC REMOVED AND FOUND TO HAVE A VERY SMALL HOLE AROUND THE 3CM MARK. LINE WAS PLACED AT 43CM 0 EXTERNAL LENGTH. MAC AT TIME OF INSERTION WAS 41CM AND STILL 41CM TODAY BRACHIAL VEIN WAS APROX 2.5 CM DEEP. AFTER REMOVAL IT WAS NOTED THE LINE WAS TRYING TO KINK AROUND THE SAME MARK WHERE THE DAMAGE WAS VISUALIZED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9960741 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page