Perifix® 332098 (UDI 04046964177385)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964177385), received between Jan 13, 2020 and Jun 15, 2025 — classified as 4 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 15, 2025Break; Break

  AS REPORTED VIA MEDWATCH NUMBER MW5170263: DESCRIBE EVENT OR PROBLEM: DURING NERVE BLOCK FIRST ATTEMPT, DIFFICULTY FEEDING THE CATHETER. REMOVED AND FOUND THAT THE TIP OF THE CATHETER HAD BROKEN, AND THE SPRING HAD UNWOUND AT THE TIP. ADDITIONALLY, BLUE CM MARKERS RUBBED OFF ON PROVIDER'S FINGERTIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208621 ↗
• MalfunctionJan 29, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CATHETER TIP CAME OFF WHILE REMOVING FROM THE PATIENT. DETAILED INQUIRY DESCRIPTION: TUOHY NEEDLE, RESISTANCE MET INTO 3-4 IN SPACE, BLUE TIP WAS NOT ON CATHETER WHEN PULLED OUT OF THE NEEDLE. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES ON (B)(6) 2024 - XRAY OF SPINE, ON (B)(6) 2024 - MRI OF SPINE.

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

  MAUDE report 18595359 ↗
• MalfunctionOct 12, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT A PATIENT WAS HAVING A BLOOD PATCH PROCEDURE IN THE ER, AND A PIECE OF THE EPIDURAL CATHETER BROKE OFF INTO THE PATIENT. PATIENT DECLINED TO HAVE THE PIECE SURGICALLY REMOVED AND HAS OPTED TO HAVE IT MONITORED. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15586271 ↗
• MalfunctionJan 13, 2020Break; Break

  AS PER MEDWATCH NUMBER (B)(4): WHEN CRNA WAS ATTEMPTING TO PUT IN THE CATHETER, SHE FELT A SLIGHT RESISTANCE AND DID NOT CONTINUE THE ADVANCEMENT OF THE CATHETER, AND EVENTUALLY DECIDED TO WITHDRAW THE CATHETER FROM THE PATIENT. IT WAS THEN NOTICED THAT THE BLUE TIP/MARKER AT THE END OF THE CATHETER WAS NOT SEEN (APPROXIMATELY A CENTIMETER) AND EDGES SEEMED FRAYED OR SHEARED OFF. XRAYS WERE TAKEN OF LUMBAR SPINE 2-3 VIEWS, CERVICAL SPINE 2-3 VIEWS AND THORACIC SPINE 2 VIEWS: NO RADIOPAQUE LINEAR DENSITY OR FOREIGN BODY NOTED (IN ALL VIEWS). NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580661 ↗