Permcath 8831692001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521009882), received between Oct 20, 2023 and Oct 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Break; Break

  ACCORDING TO THE REPORTER, AT 15:30, THE DOCTOR WAS REPLACING THE HEMODIALYSIS TUBE AND ACCESSORIES OF THE PATIENT. NEAR THE END OF THE OPERATION, WHEN PREPARING TO CONNECT THE LUER ADAPTER (STERILE INFUSION CONNECTOR) TO THE PATIENT, IT WAS DISCOVERED THAT ONE OF THE LUER ADAPTERS WAS DAMAGED. THE VENOUS/BLUE LUER ADAPTER HAD A CRACK AND A LEAK WAS OBSERVED IN THE CRACKED AREA. THE PATIENT'S PULSE RATE PER MINUTE WAS 80 TIMES/MINUTE, BREATH RATE PER MINUTE WAS 19 TIMES/MINUTE AND BP (BLOOD PRESSURE) WAS 140/85MMHG. THE PATIENT DID NOT COMPLAIN OF DISCOMFORT. TEGO WAS UTILIZED AND THE CATHETER WAS REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. IODOPHOR WAS THE CLEANING AGENT UTILIZED TO CLEAN THE ADAPTERS. THE DEVICE WAS NOT REPLACED WITH A NEW PRODUCT AND THE CATHETER WAS NOT EXPLANTED. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. A SALINE WAS USED TO FLUSH THE DEVICE PRIOR TO USE AND HAD NO ISSUES. THEY IMMEDIATELY REPLACED THE LUER ADAPTER WITH A SPARE LUER ADAPTER OR DISPOSABLE STERILE INFUSION CONNECTOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980922 ↗