Perifix® 332078 (UDI 04046964177200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04046964177200), received between Mar 30, 2017 and Mar 30, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. Jun 5, 2023Open, Classified

   Kits were assembled with the incorrect Filter Straw.

   Z-2002-2023 · Root cause: Mixed-up of materials/components · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  AS REPORTED BY THE USER FACILITY. EPIDURAL CATHETER "SHEARING OFF" IN PATIENT WHILE PROVIDER WAS ATTEMPTING TO PLACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24716498 ↗
• InjuryJun 8, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER CALLED TO REPORT THAT THE EPIDURAL BROKE AND STILL IN PATIENTS BACK. THE PATIENT HAD TO BE TRANSFER TO A NEUROSURGEON TO HAVE IT REMOVED. THIS HAPPENED DURING CHILDBIRTH (FEMALE).

  Patient problems: Foreign Body In Patient

  MAUDE report 17087233 ↗
• InjuryJun 7, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: FX CATHETER COULD NOT BE REMOVED BY NURSE. CRNA WAS CALLED IN AND MD ANESTHESIA. CATHETER BROKE JUST PROXIMAL TO PATIENT SKIN LEVEL. PATIENT WAS SENT TO HAVE CATHETER REMOVED. ADDITIONAL INFORMATION RECEIVED: DURING REMOVAL OF FX CATHETER POST LABOR, THE CATHETER BROKE OUTSIDE OF PATIENT. FIRST ATTEMPT WAS A NURSE. NEXT ATTEMPT WAS 2 CRNA'S PUTTING THE PATIENT IN VARIOUS POSITIONS, NO SUCCESS. NEXT WAS A MD ANESTHESIA AND HE/SHE HAD NO SUCCESS. PATIENT WAS SENT TO HAVE CATHETER REMOVED. NEUROSURGEON PULLED AND BROKE ANOTHER SECTION OUTSIDE OF PATIENT. THE REMAINDER OF THE CATHETER WAS SURGICALLY REMOVED. PATIENT REPORTED TO BE OK.

  Patient problems: Foreign Body In Patient

  MAUDE report 17081271 ↗
• MalfunctionAug 10, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT CLINICIAN WAS UNABLE TO THREAD EPIDURAL CATHETER BEYOND NEEDLE TIP DURING PROCEDURE. AFTER REMOVING AND PERFORMING PROCEDURE WITH ADDITIONAL DEVICE, SUSPECTED DEFECTIVE EQUIPMENT TAKEN TO ANESTHESIA WORK ROOM FOR EVALUATION. ADHERENT FRAGMENT OF THE INTERIOR NEEDLE BROKE FREE AFTER MULTIPLE MECHANICAL ADVANCEMENTS.

  Patient problems: Needle Stick/Puncture; No Known Impact Or Consequence To Patient

  MAUDE report 10385412 ↗
• MalfunctionSep 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE CATHETER CONNECTORS DISCONNECTED DURING USE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8980201 ↗
• MalfunctionSep 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE CATHETER CONNECTORS DISCONNECTED DURING USE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8980186 ↗
• MalfunctionSep 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE CATHETER CONNECTORS DISCONNECTED DURING USE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8980184 ↗
• MalfunctionMay 22, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: CATHETER CONNECTOR ARE COMING APART DURING USE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631227 ↗
• MalfunctionMay 17, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: DURING THE EPIDURAL PLACEMENT ON AN OB PATIENT, THE DOCTOR REPOSITIONED THE TOUHY NEEDLE AND ATTEMPTED TO REMOVE THE CATHETER. UPON REMOVAL, THE CATHETER GAVE RESISTANCE. THE CATHETER WAS OBSERVED TO BE SHEARED UPON REMOVAL. NO PART OF THE CATHETER WAS LEFT IN THE PATIENT. THE PATIENT REQUIRED A SECOND PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7523393 ↗
• MalfunctionMar 30, 2017Break; Break

  PER MEDWATCH: (B)(4). EVENT 3: EVENT: THREE ATTEMPTS WERE MADE AT INSERTING AN EPIDURAL CATHETER AT L3-L4 LEVEL. ON THE THIRD ATTEMPT, THE CATHETER WAS PASSED INTO WHAT APPEARED TO BE THE EPIDURAL SPACE, BASED ON THE LOSS OF RESISTANCE. AFTER THE CATHETER WAS PASSED TO 12 CM, THE PATIENT COMPLAINED OF PAIN ON THE LEFT SIDE, WHILE AT THE SAME TIME, I ENCOUNTERED RESISTANCE TO PASSING THE CATHETER FURTHER. I THEN STOPPED PASSING THE CATHETER FURTHER AND BEGAN PULLING BACK THE CATHETER AND THE NEEDLE. IMMEDIATELY AFTER STARTING TO PULL BACK, THE CATHETER BECAME LOOSE AND I NOTED THAT THE TIP OF THE CATHETER BROKE AT APPROX. 3.5CM AND WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS THEN ABORTED AND THE PATIENT IMMEDIATELY DELIVERED WITHOUT COMPLICATIONS AND WITHOUT AN EPIDURAL CATHETER. SHE REMAINED NEUROLOGICALLY INTACT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6446123 ↗
• MalfunctionMar 30, 2017Break; Break

  PER MEDWATCH: (B)(4). EVENT 2: EVENT: THREE ATTTEMPTS WERE MADE AT INSERTING AN EPIDURAL CATHETER AT L3-L4 LEVEL. ON THE THIRD ATTEMPT, THE CATHETER WAS PASSED INTO WHAT APPEARED TO BE THE EPIDURAL SPACE, BASED ON THE LOSS OF RESISTANCE. AFTER THE CATHETER WAS PASSED TO 12 CM, THE PATIENT COMPLAINED OF PAIN ON THE LEFT SIDE, WHILE AT THE SAME TIME, I ENCOUNTERED RESISTANCE TO PASSING THE CATHETER FURTHER. I THEN STOPPED PASSING THE CATHETER FURTHER AND BEGAN PULLING BACK THE CATHETER AND THE NEEDLE. IMMEDIATELY AFTER STARTING TO PULL BACK, THE CATHETER BECAME LOOSE AND I NOTED THAT THE TIP OF THE CATHETER BROKE AT APPROX. 3.5CM AND WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS THEN ABORTED AND THE PATIENT IMMEDIATELY DELIVERED WITHOUT COMPLICATIONS AND WITHOUT AN EPIDURAL CATHETER. SHE REMAINED NEUROLOGICALLY INTACT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6446121 ↗
• MalfunctionMar 30, 2017Break; Break

  PER MEDWATCH: (B)(4). EVENT 1: EVENT: THREE ATTEMPTS WERE MADE AT INSERTING AN EPIDURAL CATHETER AT L3-L4 LEVEL. ON THE THIRD ATTEMPT, THE CATHETER WAS PASSED INTO WHAT APPEARED TO BE THE EPIDURAL SPACE, BASED ON THE LOSS OF RESISTANCE. AFTER THE CATHETER WAS PASSED TO 12 CM, THE PATIENT COMPLAINED OF PAIN ON THE LEFT SIDE, WHILE AT THE SAME TIME, I ENCOUNTERED RESISTANCE TO PASSING THE CATHETER FURTHER. I THEN STOPPED PASSING THE CATHETER FURTHER AND BEGAN PULLING BACK THE CATHETER AND THE NEEDLE. IMMEDIATELY AFTER STARTING TO PULL BACK, THE CATHETER BECAME LOOSE AND I NOTED THAT THE TIP OF THE CATHETER BROKE AT APPROX. 3.5 CM AND WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS THEN ABORTED AND THE PATIENT IMMEDIATELY DELIVERED WITHOUT COMPLICATIONS AND WITHOUT AN EPIDURAL CATHETER. SHE REMAINED NEUROLOGICALLY INTACT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6446114 ↗