Perifix® 332097 (UDI 04046955899470)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046955899470), received between May 5, 2025 and Sep 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0119-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER COMPLAINT ADVOCATE CALLED THE REPORTER WHILE ENTERING THE RECORD AND HE EXPLAINED THAT THE PLASTIC PORTION OF THE CATHETER TORE OFF WHILE TRYING TO ADMINISTER THE SPINAL TO A LABORING MOM WHO WANTED AN EPIDURAL. HE ADDED THAT THE DEVICE TORE WHILE HE WAS TRYING TO PULL THE CATHETER OUT, THAT THE WIRE WAS STILL IN THE PATIENT. AS THE WIRE WAS STRETCHED OUT AND LENGTHENED AND HAD TWISTED ON ITSELF, IT WAS HARD TO TELL IF A PIECE OF THE WIRE WAS EMBEDDED IN THE PATIENT OR JUST A PIECE OF THE PLASTIC. HE IS NOT SURE IF THE WIRE BROKE OFF OR NOT. HE FEELS LIKE MAYBE HE MADE AN ERROR BY TRYING TO READJUST THE NEEDLE WHILE PULLING THE CATHETER OUT AT THE SAME TIME. THAT MAYBE THE CATHETER NEEDLE BUT THE WIRE OR THE CATHETER - HE IS NOT SURE. AS THE PATIENT WANTED TO EPIDURAL, SHE NEEDED PAIN RELIEF - HE REMOVED EVERYTHING THAT HE COULD AND PLACED ANOTHER CATHETER. A PIECE WAS LEFT IN THE PATIENT. A CT SCAN REVEALED A 1-2CM FRAGMENT EMBEDDED IN THE PATIENT. PATIENT DID DELIVER THE BABY WITHOUT AN ADDITIONAL ISSUE AND IS BEING TREATED AT ANOTHER FACILITY AS THIS IS A SMALL ESTABLISHMENT SO THE PATIENT WAS TRANSFERRED TO ANOTHER LOCATION TO BE TREAT

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 23097381 ↗
• MalfunctionMay 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: RESIDUE IN LIDOCAINE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997855 ↗
• MalfunctionMay 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: RESIDUE IN LIDOCAINE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997819 ↗
• MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: RESIDUE IN LIDOCAINE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959864 ↗
• MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: RESIDUE IN LIDOCAINE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959811 ↗