Per-Q-Cath Plus Catheter 4135105Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741074905), received between Mar 22, 2017 and Jun 15, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2022, WHEN PERFORMING A CATHETER INSERTION PROCEDURE, THE TEAM SHOWED THAT IT WAS BROKEN, WHICH MADE IT IMPOSSIBLE TO PERFORM THE CATHETER IMPLANT. IT WAS STATED THE PROCEDURE POSTPONED UNTIL NEW ITEM ARRIVES. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14706590 ↗
• MalfunctionJun 15, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, WHEN PERFORMING A CATHETER INSERTION PROCEDURE, THE TEAM SHOWED THAT IT WAS BROKEN, WHICH MADE IT IMPOSSIBLE TO PERFORM THE CATHETER IMPLANT. IT WAS STATED THE PROCEDURE POSTPONED UNTIL NEW ITEM ARRIVES. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14706473 ↗
• MalfunctionAug 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED JUGULAR R WAS PUNCTURED, PRESENTED GOOD BLOOD FLOW, METALLIC SHEATH (MANDREL) WAS REMOVED, CATHETER WAS INTRODUCED, PROGRESSING EASILY. BUT THE INTRODUCER BROKE BEFORE INSERTING THE CATHETER. INFO ADDED ON (B)(6) 2021: WAS THERE ANY HARM TO THE PATIENT? THERE WAS THE INTERRUPTION OF THE PROCEDURE, AND THE TECHNIQUE ADOPTED WAS PROVIDING ANOTHER CATHETER. THE ICU IS NEAR BY THE PHARMACY, AND THE NURSE WAS QUICK IN PROCESS. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC)? THERE WAS NONE, ONLY THE PUNCTURE WAS RESTARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380406 ↗
• MalfunctionMay 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ON (B)(6) 2021 THE PROCEDURE WAS BEGUN, AT THE MOMENT OF REMOVING THE GUIDEWIRE IT PRESENTED RESISTANCE, AND AFTER PERFORMING SOME UNSUCCESSFUL HANDLING IN AN ATTEMPT TO REMOVE IT, IT WAS REQUIRED TO REMOVE THE CATHETER. IT WAS NOTICED THAT THE CATHETER WAS RUPTURED IN ITS EXTENSION. IT SEEMS THAT THE RUPTURE WAS CAUSED BY THE GUIDEWIRE THAT GOT STUCK INSIDE THE CATHETER. THERE WAS NO EXPOSURE TO MEDICATIONS OF BODILY FLUIDS TO HEALTH PROFESSIONAL'S MUCOUS OR SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791344 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, CLIENT POINTED OUT THAT THE CATHETER BROKE AT THE HEIGHT OF THE HUB. ACCORDING TO INFORMATION COLLECTED FROM THE CLIENT, THERE WERE NO IMPACTS ON PATIENT, SUCH AS DEATH AND OTHER SIMILAR RISKS, BUT THE DAMAGE TO THE PRODUCT AND, IN A WAY, THE DELAY IN DELIVERING THE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755852 ↗
• MalfunctionApr 30, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED CLIENT POINTED OUT THAT THE CATHETER BROKE AT THE HEIGHT OF THE HUB. ACCORDING TO INFORMATION COLLECTED FROM THE CLIENT, THERE WERE NO IMPACTS ON PATIENT, SUCH AS DEATH AND OTHER SIMILAR RISKS, BUT THE DAMAGE TO THE PRODUCT AND, IN A WAY, THE DELAY IN DELIVERING THE THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755653 ↗
• MalfunctionApr 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER BROKE AT THE HEIGHT OF THE HUB. IT WAS STATED THERE WERE NO IMPACTS ON THE PATIENT, SUCH AS DEATH AND OTHER SIMILAR RISKS, BUT THE DAMAGE TO THE PRODUCT AND, IN A WAY, THE DELAY IN DELIVERING THE THERAPY. ADD INFO RCVD : INSERTION ON (B)(6) 2021, MSD INSERTED CATHETER, WHEN THE INSERT WAS FLUSHED TO TEST THE CATHETER PERMEABILITY, IT WAS OBSERVED THAT THE TUBE WAS RUPTURED, WHICH WAS NOT OBSERVED WHEN FILLING THE CATHETER BEFORE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744842 ↗
• MalfunctionApr 2, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT WHEN REMOVING THE GUIDE WIRE FROM THE CATHETER, IT FRAYED BEFORE PASSING THE CATHETER INTO PATIENT. MATERIAL USED IN A 5FR MONO LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607966 ↗
• MalfunctionFeb 8, 2019Leak/Splash

  IT WAS REPORTED A LEAK WAS FOUND IN THE CATHETER AROUND DEPTH 14CM PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8323387 ↗
• MalfunctionApr 20, 2018Split; Device Disinfection Or Sterilization Issue

  IT WAS REPORTED THAT WHILE FLUSHING PRIOR TO INSERTION THE CATHETER WAS NOTED TO BE DAMAGED AND WAS UNABLE TO BE SUCCESSFULLY FLUSHED. THE CATHETER WAS NOT USED ON THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. 3/29/2018 - THE RETURNED CATHETER HAS A LARGE SPLIT NEAR THE DISTAL HUB. THE RETURNED CATHETER ALSO HAS BLOOD RESIDUE ON THE STYLET INDICATING USE ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7448343 ↗
• MalfunctionMar 23, 2017Difficult to Remove

  IT WAS REPORTED DURING REMOVAL OF THE GUIDEWIRE, AFTER THREADING THE CATHETER WITH RESISTANCE AND TWISTING, IT WAS NECESSARY TO PUSH THE CATHETER IN 6CM TO RETURN THE CATHETER INTO CORRECT PLACEMENT. NO PATIENT HARM OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6429470 ↗
• MalfunctionMar 22, 2017Break

  IT WAS REPORTED THAT THE NEEDLE WAS INTRODUCED IN THE RIGHT JUGULAR AND THE INTRODUCER BROKE IN THE FIRST PUNCTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6424445 ↗