Perifix® 332282Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964178948), received between Sep 4, 2018 and Jun 22, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 22, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CATHETER WAS SHEARED OFF FROM TUOHY DURING EPIDURAL CATHETER PLACEMENT. DETAILED INQUIRY DESCRIPTION: CLINICIAN WAS PULLING BACK ON BOTH CATHETER AND TUOHY WHEN CATHETER SHEERED AND REMAINS IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22304555 ↗
• MalfunctionMar 8, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: "DURING PLACEMENT OF THE EPIDURAL CATHETER WITH PRODUCTS 333161 AND EPIDURAL TRAY 332282, THE 20G CATHETER FROM THE TRAY WENT INTO THE SPINAL NEEDLE HOLE IN THE TUOHY FROM 333161. THE CATHETER COULD NOT BE ADVANCED AND THE ENTIRE SETUP WAS REMOVED TOGETHER. WHEN REMOVED, IT WAS NOTED THAT THE CATHETER TIP WAS IN THE SPINAL HOLE. AN X-RAY WAS DONE BUT WE COULD NOT FIND THE CATHETER TIP."

  Patient problems: Foreign Body In Patient

  MAUDE report 11435113 ↗
• InjurySep 5, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: THE CATHETER SLIDE OUT AND APPROXIMATELY 10CM WERE LEFT INSIDE THE PATIENT. THE PATIENT DELIVERED THE BABY AND WAS SENT HOME TO RECOVER FROM PREGNANCY. LIMITED INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7846259 ↗
• InjurySep 4, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: DURING THE INITIAL PLACEMENT OF THE CATHETER FOR A PATIENT IN LABOR, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. THE FACILITY STATED THE CATHETER DID NOT THREAD EASILY, HOWEVER IT FLUSHED EASILY. WHEN THE CATHETER WAS RETRACTED, THE CLINICIAN NOTICED APPROXIMATELY 34 MM OF THE CATHETER TIP TO BE MISSING. THE CLINICIAN FLUSHED THE NEEDLE AND NO REMNANTS WERE FOUND. THE ENVIRONMENT AREA WAS ALSO CHECKED AND NO REMNANTS WERE FOUND. PATIENT HAD A NEUROSURGICAL CONSULT AND UNDERWENT A CT SCAN AND A SPINAL X-RAY. NO REMNANTS WERE FOUND ON THE SCANS OR THE X-RAY. NO FURTHER INTERVENTIONS WERE PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7842509 ↗