PowerPICC SOLO2 Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1396108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741034732), received between Mar 15, 2017 and Aug 24, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 24, 2017Crack

  FACILITY REPORTED TO THE SALES REP THAT THE CATHETER APPEARS TO HAVE A CRACK AT THE HUB. NO OTHER INFORMATION WAS REPORTED, BUT HAS BEEN REQUESTED.

  Patient problems: No Information

  MAUDE report 6817066 ↗
• MalfunctionAug 10, 2017Device Operates Differently Than Expected

  PER SALES REP, THE FACILITY REPORTED A TRIPLE LUMEN PICC WAS BEING PLACED AND ALL THREE LUMEN WERE FLUSHED WITH NO INCIDENT PRIOR TO PLACEMENT. PICC WAS PLACED WITHOUT INCIDENT, RN THEN CHECKED EACH LUMEN FOR ASPIRATION AND FLUSHED. IT WAS STATED THAT DURING FLUSHING THE WHITE SOLO VALVE "POPPED" AND SALINE/BLOOD SPLASHED OVER PLACERS GLOVES, GOWN, AND PATIENT DRAPE. THE LUMEN WAS CLAMPED WITH IV CLAMP. HOSPITALIST WAS NOTIFIED OF POTENTIAL FOR INTRODUCTION OF WHITE HUB/VALVE PARTICLES THROUGH THE LINE, AND THE DECISION WAS MADE THAT THERE WAS MINIMAL RISK, AND THE LINE WAS EXCHANGED OVER THE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6786084 ↗
• MalfunctionAug 10, 2017Break

  PER SALES REP, THE FACILITY REPORTED A PICC WHITE LUMEN BROKE DURING PRE-PLACEMENT FLUSH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6784711 ↗
• MalfunctionMar 15, 2017Fluid/Blood Leak; Fracture; Material Fragmentation

  ON 2/22/2017 - FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT 2 HOURS POST PLACEMENT, THE CATHETER WAS FLUSHED AND THE HUB "CRUMBLED" IN THE NURSES HAND. DEVICE WAS REMOVED. NO PATIENT INJURY WAS REPORTED. ON 2/23/2017 - ADDITIONAL INFORMATION REPORTED TO THE SALES REP, HEALTHCARE PROFESSIONAL (HCP) PLACED THE PICC LINE AT 5:45 PM, USING 3 CG. HCP STATED THAT THE PLACEMENT WENT WELL AND WAS FUNCTIONING PROPERLY. THE NIGHT ONCOLOGY NURSE WENT TO ACCESS PATENCY OF THE CATHETER AT 8:10 PM, BEFORE INITIATING CHEMOTHERAPY. THE PATIENT STATED THAT BLOOD WAS DRAWN FROM THE FIRST 2 LUMENS AND FLUSHED WITHOUT DIFFICULTY. WHEN THE THIRD (WHITE) LUMEN WAS ACCESSED IT FELL APART IN THE HCP HANDS. THE HCP NOTED THAT THE VALVE AREA WAS COMPRESSED, THE HCP STATED THAT BLOOD WAS EVERYWHERE. THE LINE WAS REMOVED THE FOLLOWING MORNING. THE HCP NOTED THAT THE FRACTURED LINE WAS SECURED WITH A SLIDE CLAMP OFF OF A PERIPHERAL. ALLEGED FRACTURES WERE SEEN ON BOTH SIDES OF THE VALVE HOUSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6408278 ↗