Halyard SINA234-01_0004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160326596), received between Oct 28, 2024 and Oct 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (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.

• MalfunctionOct 28, 2024Component Incompatible; Component Incompatible

  A PICC LINE STERILE SETUP WAS COMPLETED PER PROTOCOL. AFTER CATHETER WAS CUT WITH TRIM TOOL (THAT COMES WITH PICC LINE CATHETER KIT), THE LINE WAS FLUSHED WITH NSS NUMEROUS TIMES TO CHECK FOR ANY DEFECTS; NONE WERE NOTED BEFORE INSERTION. AFTER ACCESS WAS GAINED, PICC CATHETER WAS THREADED THROUGH THE TRANSDUCER WITH FORCEPS (SPLINTER, 4.5 FINE POINT) THAT ARE INCLUDED IN THE NEONATAL PROCEDURE PICC PACK. ONCE LINE WAS THREADED AND TRANSDUCED WAS REMOVED, LINE WAS FLUSHED AND NOTED TO BE LEAKING AT THE INSERTION SITE. THE LINE WAS REPOSITIONED AND FLUSHED AGAIN; LEAK WAS STILL OBSERVED. THE PHYSICIAN WAS NOTIFIED OF THE LEAK AND CAME TO THE PATIENT'S BEDSIDE. THE LINE WAS PULLED BACK APPROXIMATELY 3 CM AND A HOLE WAS NOTED IN THE CATHETER AND THE LINE WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED ON OCTOBER 10, 2024, OCTOBER 14, 2024, AND OCTOBER 16, 2024, WITH NO RESPONSE RECEIVED FROM THE CUSTOMER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20547518 ↗