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Per-Q-Cath Plus Catheter 4132000Recalls & reported problems

Bard Access Systems, Inc. · Per-Q-Cath Plus Catheter 2F Intermediate Tray (Single-Lumen) (30 cm) · Class 2 · Implant

All models of Per-Q-Cath Plus Catheter (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741035203), received between Aug 30, 2018 and Nov 2, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Device problems

  • Leak/Splash2
  • Break1
  • Failure to Advance1

Patient problems

  • No Known Impact Or Consequence To Patient3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 2, 2022Break; Break

    IT WAS REPORTED AT THE MOMENT OF PLACING THE CATHETER, EVERYTHING SEEMS TO BE FINE, HOWEVER, AFTER A SHORT TIME THE PERQCATH CATHETER BREAKS OFF THE DISTAL FRAGMENT FOR NO APPARENT REASON, A GUMMY CONSISTENCY IS OBSERVED IN THE LUMEN WHEN IT IS REMOVED. "ADDITIONAL INFORMATION RECEIVED ON OCT 24 2022: AT WHAT TIME DURING DEVICE USE (IE INSERTION, INFUSION) DID THE RUPTURE OCCUR? A: BEING PLACED ON THE PATIENT DURING DRUG INFUSION. DID ANY PART OF THE CATHETER REMAIN IN THE PATIENT? REGARDING THIS QUESTION, WAS THE COMPLETE CATHETER OBTAINED? A: NOTHING WAS LEFT INSIDE THE PATIENT. IF YES, WAS SURGERY REQUIRED TO REMOVE THE BROKEN PIECE? A: NO WERE ALL MISSING/BROKEN PARTS RECOVERED AND ACCOUNTED FOR? A: YES, IT WAS BROKEN INTO 2 PIECES AND THE CONSISTENCY OF THE DEVICE MATERIAL BECAME GUMMY. LONG-TERM HARM TO THE PATIENT? A: NONE, JUST THAT A NEW DEVICE OF A DIFFERENT BRAND REQUESTED BY THE TREATING PHYSICIAN HAD TO BE REPLACED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15713858 ↗
  • MalfunctionFeb 27, 2019Leak/Splash

    IT WAS REPORTED THAT THE CATHETER HAS A LEAK IN TWO TRAYS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8374818 ↗
  • MalfunctionFeb 27, 2019Leak/Splash

    IT WAS REPORTED THAT THE CATHETER HAS A LEAK IN THE TWO TRAYS. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8374816 ↗
  • MalfunctionAug 30, 2018Failure to Advance

    IT WAS REPORTED DURING THE INSTALLATION OF THE CATHETER THEY NOTICED THAT AFTER THE LENGTH OF 12CMS THE CATHETER COULDN'T ADVANCE MORE. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7835628 ↗

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Sources and updates

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