Perifix® 333512Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04046963899202), received between Feb 21, 2017 and Jan 16, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Break

  AS REPORTED BY THE USER FACILITY: PRODUCT QUALITY EXCELLENCE WAS INCLUDED IN AN EMAIL STRING WHERE THE CHIEF OF ANESTHESIA INQUIRED ABOUT THE TIPS BREAKING OFF OF THE B. BRAUN EPIDURAL CATHETERS. ON (B)(6) 2026, CUSTOMER COMPLAINT ADVOCATE SPOKE TO THE CLINICAL PROCEDURE SPECIALIST WHO REPORTED THAT THE CHIEF OF ANESTHESIA REPORTED THAT SHE HEARD (FROM A COLLEAGUE) THAT B. BRAUN HAD ISSUES WITH THE TIPS BREAKING AND HE WANTED TO KNOW IF IT WAS RESOLVED. WHILE THE END USER DID NOT HAVE AN EVENT OCCUR WITH BREAKAGE, THIS COMPLAINT IS BEING FILED FOR THE THIRD-PARTY EVENT WITH NO ADDITIONAL INFORMATION BEING PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101405 ↗
• MalfunctionJun 7, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: WHEN IT WAS BEING REMOVED FROM THE PATIENT, THE ANESTHESIOLOGIST NOTICED A DIFFERENT FEELING WHEN LIGHTLY PULLING ON THE ITEM. WHEN FULLY REMOVED THEY NOTICED THE LAST ESTIMATED 3 TO 4 INCHES OF THE CATHETER, WAS NO LONGER ATTACHED TO THE REST OF THE ITEM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483949 ↗
• MalfunctionDec 5, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: PER HEALTH CANADA: PATIENT REQUESTED EPIDURAL. DURING INSERTION RESISTANCE WAS FELT BY ANESTHESIA AND THE TUBING WAS PULLED OUT. IT WAS NOTED WHEN CATHETER WAS REMOVED THE TIP WAS NOT VISIBLE AND THE TUBING APPEARED TO BE SHEARED AND THE METAL GUIDE WIRE HAD BEEN PULLED OUT OF THE TUBING. CT REVEALED TIP IS IN AREA OF L4. EXTENT OF INJURY: A. TEMPORARY NOT REQUIRING MEDICAL INTERVENTION. B. MODERATE TO SERIOUS - TEMPORARY INJURY REQUIRING MEDICAL INTERVENTION - AS OF NOV 1/23 - PATIENT REMAINED ASYMPTOMATIC BUT REMAINS INVOLVED WITH MEDICAL TEAM TO DETERMINE LONG-TERM PLAN (LEAVE IN-SITU VS. SURGICALLY REMOVE) - METAL COMPONENT OF THE TIP HAS COMPLICATED THIS. C. SEVERE TO CRITICAL - PERMANENT INJURY THAT IS NOT REVERSIBLE D. LIFE THREATENING - LIFE THREATENING INJURY OR DEATH HAS OR COULD OCCUR MEDICAL INTERVENTION PERFORMED: A. NO INTERVENTION B. NATURE OF INTERVENTION · CT SCAN TO CONFIRM TIP AND LOCATION (SEPT 27) - 3.5 CM PIECE WITHIN THE EPIDURAL SPACE (FROM UPPER L3 TO L3-L4 LEVEL). · CONSULTATION WITH SPINE-SURGEON ON CALL (SEPT 27) - RECOMMENDED LEAVE IN SITU. · INTERVENTIONAL RADIOLOGY FELLOW CONTACTED (SEPT 28)- NOT ABLE TO SUCCESSFULLY

  Patient problems: Foreign Body In Patient

  MAUDE report 18271184 ↗
• MalfunctionAug 31, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: FX CATHETER FRACTURED DURING REMOVAL. UPON REMOVAL OF FX CATHETER, THE POLAMIDE COATING FRACTURED AT APPROX 5 CM FROM DISTAL END LEAVING THE WIRE EXPOSED. FULL REMOVAL WAS ACCOMPLISHED JUST TOOK MORE TIME AND ATTENTIVE CARE TO REMOVE THE CATHETER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660883 ↗
• MalfunctionJul 1, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 4: DESCRIPTION SUMMARY: PER CUSTOMER, " THE EPIDURAL CATHETER FALLS APART WHILE BEING INFUSED TO THE PATIENT". NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888479 ↗
• MalfunctionJul 1, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 2: DESCRIPTION SUMMARY: PER CUSTOMER, " THE EPIDURAL CATHETER FALLS APART WHILE BEING INFUSED TO THE PATIENT". NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888371 ↗
• MalfunctionJul 1, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 3: DESCRIPTION SUMMARY: PER CUSTOMER, " THE EPIDURAL CATHETER FALLS APART WHILE BEING INFUSED TO THE PATIENT". NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888326 ↗
• MalfunctionJul 1, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 1: DESCRIPTION SUMMARY: PER CUSTOMER, " THE EPIDURAL CATHETER FALLS APART WHILE BEING INFUSED TO THE PATIENT". NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14888266 ↗
• MalfunctionJun 8, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE CATHETER BROKE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10128070 ↗
• MalfunctionJun 8, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE CATHETER BROKE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10128069 ↗
• MalfunctionJun 8, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT THE CATHETER BROKE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10128068 ↗
• MalfunctionJul 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE CATHETER CONNECTORS ARE DISCONNECTING DURING USE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8770960 ↗
• MalfunctionJul 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE CATHETER CONNECTORS ARE DISCONNECTING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8770957 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY VIA (B)(4): NURSING STAFF NOTED THAT THE EPIDURAL CATHETER CAME APART FROM THE CONNECTOR. THE CATHETER WAS GOING INTO PATIENT'S BACK WHILE PATIENT WAS LYING ON THE BED, BECOMING CONTAMINATED. THE CONNECTION SITE WAS TAPED. THE PATIENT IN THIS EVENT REQUIRED FIVE (5) ATTEMPTS BEFORE THIS CATHETER WAS SUCCESSFULLY PLACED AND BECAME CONTAMINATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574875 ↗
• InjuryNov 7, 2017Break; Break

  AS REPORTED BY USER FACILITY: THE PATIENT RECEIVED AN OBSTETRICAL EPIDURAL INSTALLATION FOR LABOR DELIVERY. THE EPIDURAL CATHETER BROKE DURING REMOVAL WHICH CAUSED A PIECE, ABOUT 5CM IN SIZE, OF THE MEMBRANE TO BE LEFT IN THE PATIENT. THE PATIENT HAD THE PIECE SURGICALLY REMOVED POST LABOR DELIVERY. NO COMPLICATIONS OCCURRED DURING THE SURGICAL PROCEDURE TO REMOVE THE CATHETER PIECE. PATIENT STATUS IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7007837 ↗
• MalfunctionFeb 21, 2017Break; Break

  AS REPORTED BY USER FACILITY: AFTER PLACEMENT OF AN EPIDURAL CATHETER, IT WAS NOTED THERE WAS A DISRUPTION IN THE CATHETER'S INTEGRITY. THIS CAUSED INJECTED MEDICAL TO LEAK OUT. THE CATHETER DID BREAK AND PORTION WAS IN PATIENT. PATIENT REQUIRED SURGERY TO REMOVE PIECE OF CATHETER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6345716 ↗