Permcath 8834369001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521009902), received between Jun 13, 2018 and Feb 21, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

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

• MalfunctionFeb 21, 2023Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN FLUSHING WAS PERFORMED TO CHECK THE FLOW THROUGH THE CATHETER WITH SALINE, LEAKAGE WAS NOTED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, AND THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THE PROCEDURE WAS ABORTED AS THE REMEDIAL ACTION DONE TO ADDRESS THE ISSUE AND THE CATHETER WAS PACKED. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE CATHETER SHAFT BUT NOT AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THERE WAS NO LUER ADAPTER ISSUE, TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409378 ↗
• InjuryJul 21, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN THE PATIENT UNDERWENT FOR HEMODIALYSIS TREATMENT AT THE END OF MAY THIS YEAR, IT WAS FOUND THAT THERE WAS BLEEDING AT THE EXIT SITE OF THE PATIENT¿S TUNNEL (CATHETER'S BODY). IN JUNE, THE PATIENT DEVELOPED SYMPTOMS OF INFECTION AND SUSPECTED FOR PIPELINE PROBLEMS. AFTER FURTHER CLINICAL EXAMINATION, THERE WAS NO INFECTION OBSERVED ON THE PATIENT AND THE PATIENT WAS CONTINUOUSLY HOSPITALIZED. THEY PULLED OUT THE TUBE, AND IT WAS FOUND THAT THE TUBE BODY WAS BROKEN (CRACK) NEAR THE CUFF. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE, THE TREATMENT WAS PROCEEDED AND COMPLETED. THERE WAS A BLOOD LOSS OF 10 ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. FLUSHING WAS PERFORMED PRIOR TO USE WITH A NORMAL RESULT, THERE WAS NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, IODOPHOR WAS USED TO CLEAN THE ENTIRE CATHETER AND TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. BACTROBAN WAS UTILIZED AT THE EXIT SITE, THERE WAS NO CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES ON THE WOUND DRESSING, THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING THE OINTMENT TO THE AREA, THE CLEANING AGENT WAS NOT MIXED AND THE PATIENT WAS NOT USING ANY TYPE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203007 ↗
• InjuryMar 4, 2019Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER WAS CORRUPTED/BROKE IN THE PATIENTS PLEURA REGION. THERE WAS A LEAK IN THE INTRA PLEURA. IT WAS STATED THAT THE INSERTION SITE WAS VIA INTRA-ATRIAL THORACOTOMY. CHLORHEXIDINE WAS USED AS A CLEANING AGENT. A MEDICAL INTERVENTION WAS DONE TO RELOCATE THE CATHETER AND IMPLANT ANOTHER AND PATIENT WAS INJECTED WITH ELECTROLYTE SOLUTION. THE CATHETER WAS REPLACED. THE HEMODIALYSIS TREATMENT WAS DELAYED. THE PATIENT HOSPITALIZATION WAS EXTENDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8386789 ↗
• MalfunctionJun 13, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CATHETER COULD NOT PASS THROUGH THE PULL APART SHEET OR FLOW GUARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597214 ↗