Palindrome 8888541128Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521135550), received between Jul 22, 2020 and Jul 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2020Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS, THE DIALYSIS MACHINE DREW AIR AND AIR BUBBLES WERE VISIBLE. CRACK AND LEAK WERE SEEN ON THE (RED) ARTERIAL CONNECTOR (LUER ADAPTER). IT WAS STATED THAT THE CATHETER WAS PLACED ONLY 6 DAYS, OCTENISEPT ALCOHOL 90% WAS USED TO CLEAN THE DEVICE. TEGO WAS UTILIZED, IT WAS STATED THAT THE THEY THIGH TEN THE DEVICE BY HAND. OCTENISPT ALCOHOL FREE WAS USED TO CLEAN THE DEVICE, INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT, THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE CATHETER WAS REPAIRED USING THE REPAIR KIT AND EVERYTHING WAS OKAY. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306781 ↗