Per-Q-Cath Plus Catheter 4134105Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741074875), received between Dec 4, 2015 and Jul 25, 2024 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, PICC PASSAGE ATTEMPTED, BUT THE INDUCTOR IS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824686 ↗
• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE CATHETER WAS OPENED FOR PRE-FLUSHING, IT WAS FOUND THAT THE CATHETER WAS BROKEN AND LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638748 ↗
• MalfunctionMay 17, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT UPON OPENING OF THE MIDLINE¿S PACKAGE, THE PROXIMAL END OF THE GUIDE WIRE INSIDE WAS FOUND BENT. IT WAS NOT SURE IF THE CATHETER WAS DAMAGED OR NOT. THE PRODUCT WAS THEREFORE UNUSABLE. (B)(6) 2023 - THE CUSTOMER REPORTED A BENT GUIDEWIRE HOWEVER A STYLET WAS RETURNED FOR EVALUATION AND EXHIBITED MULTIPLE BENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950903 ↗
• MalfunctionAug 18, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED DURING 4FR PICC PLACEMENT ATTEMPT, THE INTRODUCER BROKE PRIOR THE INSERTION. THERE WAS NO IMPACT TO PATIENT OR ANY MEDICAL INTERVENTION REQUIRED. ON (B)(6)2022 - THE SHEATH OF THE RETURNED DEVICE WAS OBSERVED TO BE PARTIALLY SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255383 ↗
• InjuryJul 13, 2022Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED THAT A TECHNICAL COMPLAINT REGARDING THE MATERIAL CENTRAL CATHETER INSERCAO PERIF. PICC 4FR X 65CM BECAUSE DURING THE PROCEDURE OF PASSING THE CATHETER AFTER PUNCTURE, THE MATERIAL BROKE CAUSING DAMAGE TO THE PATIENT'S BLOOD VESSEL AND ALSO CAUSING EDEMA AT THE SITE WITH RISK OF EXTENSIVE HEMATOMA. IT WAS IMMEDIATELY WITHDRAWN. ON 06/27/2022: ADD INFO RECEIVED: WAS THERE ANY HARM, OTHER THAN WHAT WAS MENTIONED, TO THE PATIENT? YES, PATIENT HAD BRUISES. WHAT WAS DONE TO CONTINUE TREATMENT? ANOTHER TYPE OF CATHETER WAS PASSED INTO THE PATIENT. HAS THERE BEEN BLOOD OR CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES OR SKIN? YES. WHAT MEDICATION WAS BEING ADMINISTERED? NONE. WAS THERE A NEED FOR MEDICAL INTERVENTION DUE TO THE EVENT (IMAGING EXAMS, MEDICATION ADMINISTRATION, ETC)? NO.

  Patient problems: Bruise/Contusion; Perforation; Swelling/ Edema

  MAUDE report 15005554 ↗
• MalfunctionApr 1, 2022Material Frayed; Improper or Incorrect Procedure or Method; Material Frayed; Improper or Incorrect Procedure or Method

  IT WAS REPORTED GUIDE WIRE FRAYED THUS MAKING IT IMPOSSIBLE TO PASS THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978905 ↗
• MalfunctionNov 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER THE PACKAGE OF THE NEW CATHETER WAS OPENED, THE STYLET WAS FOUND BENT. IT WAS STATED THIS MADE IT IMPOSSIBLE TO PLACE THE CATHETER IN THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790866 ↗
• MalfunctionAug 27, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC CATHETER HAS A FRAYED WIRE, WHERE AT PULLING THE INTERNAL PART OF THE WIRED REMAINED, BEING OBSERVED BEFORE FLUSHING." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378284 ↗
• MalfunctionSep 25, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE BEVEL BROKE IN THE FIRST PUNCTURE ATTEMPT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120988 ↗
• MalfunctionSep 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE NURSE THAT AFTER REMOVING THE GUIDEWIRE AND PERFORMING SALINIZATION OF THE CATHETER, HE COULD OBSERVE A LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112782 ↗
• MalfunctionMar 26, 2019Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GUIDE WIRE GOT STUCK. THE ATTEMPT HAPPENED IN THE UPPER LIMB GUIDED BY DOPPLER ULTRASOUND. (B)(6) 2019 - RETURNED WIRE IS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8453842 ↗
• MalfunctionNov 15, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER DETACHED FROM THE HUB DURING CHEMOTHERAPY INFUSION. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8076127 ↗
• MalfunctionNov 15, 2018Material Puncture/Hole

  IT WAS REPORTED THAT THE AFTER INSERTION A HOLE WAS NOTICED IN THE CATHETER. THE ATTEMPT HAPPENED IN THE UPPER LIMB GUIDED BY DOPPLER ULTRASOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8076066 ↗
• MalfunctionNov 2, 2018Material Twisted/Bent

  DURING INSERTION OF PERQ BASIC KIT IN PATIENTS THE CATHETER ALONG WITH STYLET BEND INSIDE THE VEIN AND UNABLE TO DO THE PROCEDURE. IT WAS STATED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034642 ↗
• MalfunctionNov 2, 2018Material Twisted/Bent

  DURING INSERTION OF PERQ BASIC KIT IN PATIENTS THE CATHETER ALONG WITH STYLET BEND INSIDE THE VEIN AND UNABLE TO DO THE PROCEDURE. IT WAS STATED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034639 ↗
• MalfunctionNov 2, 2018Material Twisted/Bent

  DURING INSERTION OF PERQ BASIC KIT IN PATIENTS THE CATHETER ALONG WITH STYLET BEND INSIDE THE VEIN AND UNABLE TO DO THE PROCEDURE. IT WAS STATED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034635 ↗
• MalfunctionNov 2, 2018Material Twisted/Bent

  DURING INSERTION OF PERQ BASIC KIT IN PATIENTS THE CATHETER ALONG WITH STYLET BEND INSIDE THE VEIN AND UNABLE TO DO THE PROCEDURE. IT WAS STATED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Information

  MAUDE report 8033492 ↗
• MalfunctionSep 26, 2017Material Rupture

  IT WAS REPORTED THAT THE MATERIALS TO BE USED TO PREPARE INSTALLATION OF CATHETER WERE OPENED TO PICK THE CATHETER AND WHEN PURGING THE SAME, THERE WAS A RUPTURE OF THE CATHETER IN THE CONNECTION SITE WITH THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6895603 ↗
• MalfunctionJul 21, 2017Split

  IT WAS REPORTED RESISTANCE OF THE INTRODUCER BY PASSING THROUGH THE SKIN. BY REMOVING IT WAS OBSERVED THAT THE TIP OF THE INTRODUCER WAS SPLITED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6733484 ↗
• InjuryDec 4, 2015Break

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY BROKE AND IT WAS NECESSARY TO PERFORM A VENOTOMY TO TAKE THE REMAINING PICC OUT OF THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 5268728 ↗