PowerPICC SOLO2 Catheter 3396108Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741028397), received between Jul 5, 2017 and Aug 18, 2017 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2017Break

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD A PICC BREAK AFTER INSERTION. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803430 ↗
• MalfunctionAug 17, 2017Crack

  IT WAS REPORTED BY THE FACILITY THAT THE LINE WAS SUCCESSFULLY INSERTED WITHOUT ISSUE, HOWEVER THE FOLLOWING DAY THE WHITE PORT ON THE 6FR TRIPLE LUMEN WAS CRACKED DOWN THE HUB. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802566 ↗
• MalfunctionAug 3, 2017Crack

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD A DEFECTIVE PICC. IT WAS REPORTED BY THE FACILITY THAT THE LINE WAS NEVER INSERTED DUE TO PRE-INSERTION DISCOVERY OF THE HUB CRACK, A NEW KIT WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6765686 ↗
• MalfunctionJul 5, 2017Break; Crack

  IT WAS REPORTED BY THE FACILITY THAT THEY HAVE HAD SIX PICC'S BREAK WHERE THE CONNECTOR IS, THEY STATED IT APPEARED TO BE CRACKING. NO PATIENT INJURY WAS REPORTED. THIS FILE ADDRESSES PATIENT FOUR. ON (B)(6) 2017-FACILITY REPORTED USE OF CHLOROHEXIDINE AND PLACES SWABCAPS ON THE PICC LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685947 ↗
• MalfunctionJul 5, 2017Break; Crack

  IT WAS REPORTED BY THE FACILITY THAT THEY HAVE HAD SIX PICC'S BREAK WHERE THE CONNECTOR IS, THEY STATED IT APPEARED TO BE CRACKING. NO PATIENT INJURY WAS REPORTED. THIS FILE ADDRESSES PATIENT SIX. ON (B)(6) 2017 - FACILITY REPORTED USE OF CHLOREHEXADINE AND PLACES SWABCAPS ON THE PICC LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685940 ↗
• MalfunctionJul 5, 2017Break; Crack

  IT WAS REPORTED BY THE FACILITY THAT THEY HAVE HAD SIX PICC'S BREAK WHERE THE CONNECTOR IS, THEY STATED IT APPEARED TO BE CRACKING. NO PATIENT INJURY WAS REPORTED. THIS FILE ADDRESSES PATIENT THREE. (B)(6) 2017 - FACILITY REPORTED USE OF CHLOREHEXADINE AND PLACES SWABCAPS ON THE PICC LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685934 ↗
• MalfunctionJul 5, 2017Crack

  IT WAS REPORTED BY THE FACILITY THAT THEY HAVE HAD SIX PICC'S BREAK WHERE THE CONNECTOR IS, THEY STATED IT APPEARED TO BE CRACKING. NO PATIENT INJURY WAS REPORTED. THIS FILE ADDRESSES PATIENT FIVE. ON (B)(6) 2017 - FACILITY REPORTED USE OF CHLORHEXIDINE AND PLACES SWABCAPS ON THE PICC LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685932 ↗
• MalfunctionJul 5, 2017Break; Crack

  IT WAS REPORTED BY THE FACILITY THAT THEY HAVE HAD SIX PICC'S BREAK WHERE THE CONNECTOR IS, THEY STATED IT APPEARED TO BE CRACKING. TNO PATIENT INJURY WAS REPORTED. HIS FILE ADDRESSES PATIENT TWO. ON (B)(6) 2017, FACILITY REPORTED USE OF CHLOROHEXIDINE AND PLACES SWAB CAPS ON THE PICC LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685930 ↗
• MalfunctionJul 5, 2017Crack

  IT WAS REPORTED BY THE FACILITY THAT THEY HAVE HAD SIX PICC'S BREAK WHERE THE CONNECTOR IS, THEY STATED IT APPEARED TO BE CRACKING. ONE SAMPLE TO BE RETURNED. THIS FILE ADDRESSES PATIENT ONE. NO PATIENT INJURY WAS REPORTED. 6/26/2017 - FACILITY REPORTED USE OF CHLOREHEXADINE AND PLACES SWABCAPS ON THE PICC LUMENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685929 ↗