BARD Poly Midline 4154108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741037665), received between Aug 18, 2016 and Apr 19, 2017 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2017Leak/Splash

  IT WAS REPORTED BY THE FACILITY THAT THE CATHETER LEAKED DURING INSERTION WHILE FLUSHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6504548 ↗
• MalfunctionAug 18, 2016Fluid/Blood Leak

  ON 7/26/2016- PER SALES REPRESENTATIVE, USER FACILITY REPORTED THAT A MIDLINE CATHETER LEAKED AFTER TWO DAYS AND WAS REMOVED AND REPLACED. ON 08/08/2016 - FACILITY CONTACT REPORTED THAT THE MIDLINE LEAK WAS LOCATED "OUTSIDE/INSIDE THE LUMEN". CONTACT STATED THAT HE DID NOT NICK THE SKIN BUT NOTICED AFTER A FEW DAYS THAT THE BIO PATCH BECAME WET AFTER THE PATIENT RECEIVED IV ANTIBIOTICS. HE STATED THAT WHEN THE CATHETER WAS FLUSHED, THERE WAS A LEAK COMING FROM THE EXIT SITE. HE REPORTED THAT WHEN HE WAS CHANGING THE DRESSING AND FLUSHED THE LINE, "A SUDDEN GUSH OF BLOOD CAME OUT FROM THE EXIT SITE". HE REPORTED HE INSERTED THIS LINE. THE CATHETER WAS DISCONTINUED AND HE NOTICED THE CATHETER WAS "CROOKED, NOT STRAIGHT." ON 08/08/2016 - FACILITY CONTACT REPORTED THAT THE CATHETER WAS PLACED IN THE UPPER ARM AND NEVER IN THE AC. THEY USE THE BASILICA OR CEPHALIC VEIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5886834 ↗