Pristine 5403190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741219030), received between Apr 7, 2023 and Jun 1, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Restricted Flow rate; Deformation Due to Compressive Stress; Restricted Flow rate; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SOME TIME POST A DIALYSIS CATHETER PLACEMENT, THE TUBING NEAR THE HUB ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY HAD POOR FLOW. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036860 ↗
• MalfunctionMay 9, 2023Fracture; Material Separation; Difficult or Delayed Separation; Fracture; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE SHEATH ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE DEVICE PEELED AWAY, AND THE HANDLE OF THE SHEATH BROKE OFF. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892923 ↗
• MalfunctionApr 27, 2023Difficult to Flush; Suction Problem; Obstruction of Flow; Difficult to Flush; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT SIX DAYS POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY CLOTTED. IT WAS FURTHER REPORTED THAT THE CATHETER DID NOT WORK. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826704 ↗
• MalfunctionApr 17, 2023Fracture; Material Separation; Difficult or Delayed Separation; Fracture; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE SHEATH ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE DEVICE PEELED AWAY AND THE HANDLE OF THE SHEATH BROKE OFF. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750843 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION WAS ALLEGEDLY DEVELOPED IN THE PATIENT¿S CENTRAL LINE. IT WAS FURTHER REPORTED THAT CULTURE WAS TAKEN FROM THE LINE AND LABORATORY INFECTION CONFIRMED THE GROWTH OF SPHINGOMONAS PAUCIMOBILIS BACTERIA. FURTHERMORE, PATIENT ALLEGEDLY HAD URINARY TRACT INFECTION AND EXPERIENCED SYMPTOMS OF TACHYCARDIA, HYPOTENSION, LETHARGY, AND FEVER. REPORTEDLY, ANTIBIOTICS WERE ADMINISTERED TO TREAT CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Urinary Tract Infection

  MAUDE report 16704341 ↗