Perifix® 332079 (UDI 04046964177224)Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04046964177224), received between Nov 28, 2016 and May 26, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Break” (30 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. Jan 22, 2024Open, Classified

   Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.

   Z-1149-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: AN ADDITIONAL UNANNOUNCED SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS RECEIVED WITH NO KNOWN REPORTED DEFECT. HOWEVER, EVALUATION IDENTIFIED BLOODLINE LEAKAGE DUE TO A DAMAGED LOCKSITE. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25280050 ↗
• MalfunctionMay 11, 2026Break

  AS REPORTED VIA MEDSUN (B)(4): IN (B)(6) 2026, DURING PLACEMENT OF AN EPIDURAL CATHETER, THE ANESTHESIOLOGIST OBSERVED THAT THE CATHETER HAD SHREDDED WHILE BEING ADVANCED INTO THE PATIENT'S BACK. THE BLUE TIP WAS NOTED TO BE MISSING FROM THE DISTAL END OF THE CATHETER. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136212 ↗
• MalfunctionApr 20, 2026Break

  AS REPORTED BY THE USER FACILITY: FX CATHETER SNAPPING DURING THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924659 ↗
• MalfunctionApr 20, 2026Break

  AS REPORTED BY THE USER FACILITY: SEVERAL CRNAS HAVE REPORTED AT LEAST 3 CATHETER DISCONNECTS OR BROKEN CATHETERS. IT IS UNCLEAR IF THE CATHETER SLIPPED OUT OF THE CONNECTOR OR IF THE CATHETER BROKE OFF. AT LEAST ONE INCIDENT REPORTED WHERE CATHETER "BROKE" AND A PIECE OF THE CATHETER REMAINED IN THE CONNECTOR. IN ADDITION, A CRNA OPENED A TRAY (332079) LOT 0062048547 AND APPLIED GENTLE/CONSTANT PULL TO THE CATHETER ON BOTH ENDS RESULTING IN THE CATHETER TO SNAP AND COME APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924583 ↗
• MalfunctionAug 13, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: PER CUSTOMER DESCRIPTION "EPIDURAL CATHETER SHREDDED UPON REMOVAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792896 ↗
• MalfunctionApr 1, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: ISSUE: THE PATIENT HAD THE EPIDURAL PLACED BY ANESTHESIA. LATER ON IN THE DAY SHE STARTED TO COMPLAIN OF SEVERE PAIN. WHEN THE ANESTHESIOLOGIST WENT TO EVALUATE HER AND TRACED THE LINE, HE SAW THAT THE TOP YELLOW ROUND PORTION OF THE CATHETER HAD BROKEN OFF AND THE ENTIRE BED WAS WET.

  Patient problems: Pain

  MAUDE report 21741113 ↗
• MalfunctionMar 12, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: EPIDURAL CATHETER BROKE OFF INTO PATIENT, NEEDED TO PERFORM A SPINAL PROCEDURE TO REMOVE THE BROKEN OFF CATHETER PIECE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21586187 ↗
• MalfunctionFeb 21, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: FX SPRINGWOUND CATHETER FELL APART WHILE BEING REMOVED FORM A PATIENT REQUIRING SURGERY TO REMOVE ANY LEFT OVER PIECES OF THE CATHETER LEFT INSIDE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21432053 ↗
• MalfunctionFeb 5, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: CATHETER WAS TORN/FRAYED WHEN THE PATIENT WAS TURNED OVER BY THE FAMILY MEMBER BY TUGGING ON THE GOWN, THIS HAPPENED RIGHT ABOVE WHERE IT WAS TAPPED TO THE BACK OF THE PATIENT. THE REMAINDER OF THE CATHETER WAS REMOVED INTACT WITHOUT ANY HARM TO THE PATIENT. ANESTHESIA DID NOT FEEL AN X-RAY WAS NEEDED AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21313811 ↗
• MalfunctionJan 24, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: THE PATIENT HAD THE EPIDURAL PLACED BY ANESTHESIA. LATER IN THE DAY SHE STARTED TO COMPLAIN OF SEVERE PAIN. WHEN THE ANESTHESIOLOGIST WENT TO EVALUATE HER AND TRACED THE LINE, HE SAW THAT THE TOP YELLOW ROUND PORTION OF THE CATHETER HAD BROKEN OFF AND THE ENTIRE BED WAS WET.

  Patient problems: Pain

  MAUDE report 21233298 ↗
• MalfunctionJul 2, 2024Break; Break

  AS REPORTED BY USER FACILITY: BRIEF INQUIRY DESCRIPTION: FX CATHETER REMOVAL INCOMPLETE. DETAILED INQUIRY DESCRIPTION: A PORTION OF FX CATHETER REMAINED INSIDE PATIENT. DESCRIPTION OF THE PATIENT EVENT: UPON ATTEMPTED REMOVAL OF FX CATHETER, A PORTION REMAINED INSIDE PATIENT LIVE CALL RECEIVED ON (B)(6) 2024: ON (B)(6) 2024 PATIENT WAS IN LABOR AND DELIVERY. STAFF ADMINISTERED AN EPIDURAL AND NOT PROBLEMS PUTTING THE CATHETER IN BUT ONCE THEY WENT TO REMOVE IT PART OF THE DEVICE STAYED IN THE PATIENT AS IT HAD BROKEN OFF. THE DEVICE WAS NOTED TO BE FRAYED AND THREADED OUT. THE PATIENT WAS ABLE TO DELIVER AND THERE WAS NO IMPACT TO THE CHILDBIRTH. PATIENT BEING TRANSFERRED TO A NEUROSURGEON TO SEE IF HE CAN REMOVE THE DEVICE (MAY HAVE BEEN TRANSFERRED LAST NIGHT OR MAY GO TODAY). IT IS UNKNOWN IF SHE WILL BE NUMBER LOCALLY OR IF SHE HAS TO GO UNDER ANESTHESIA. THE REPORTER DOES NOT HAVE ANY IDEA CLINICALLY HOW THIS WILL BE PERFORMED. REPORTER WILL PROVIDE ADDITIONAL INFORMATION REGARDING THE ATTEMPT TO REMOVE AND THE PATIENT STATUS AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19655972 ↗
• MalfunctionJul 2, 2024

  CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) OPENED EPIDURAL TRAY; A DEAD FLY WAS WRAPPED IN THE CLEAR PLASTIC COVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655085 ↗
• MalfunctionMay 24, 2024Break; Break

  ACCORDING TO MEDWATCH USER FACILITY REPORT (B)(4): DURING INSERTION OF THE EPIDURAL CATHETER THROUGH THE NEEDLE, THE CATHETER DID NOT THREAD PAST 12 CM. ATTEMPTS TO WITHDRAW THE CATHETER BACK WERE FUTILE AS THE CATHETER REMAINED STUCK AT APPROXIMATELY 10 CM. DURING ONE SUCH ATTEMPT, THE CATHETER SNAPPED AND THE ENTIRE CATHETER WITH THE WIRE CAME OUT EXCEPT FOR THE BLUE TIP AT THE END. EPIDURAL WAS RESITED WITH A DIFFERENT SET AND PATIENT HAD A GOOD OUTCOME FOR LABOR AND DELIVERY. THE POSSIBILITY OF A CATHETER FRAGMENT LEFT BEHIND WAS IMMEDIATELY DISCLOSED TO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 19392433 ↗
• MalfunctionApr 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: PARTICULATE MATTER IN LOR SYRINGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011153 ↗
• MalfunctionMar 15, 2024Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CRNA TRIALING 332079 EPIDURAL TRAY HAD A WET TAP. DETAILED INQUIRY DESCRIPTION: HOSPITAL IS CONVERTING FROM ARROW AND IS IN AN ADJUSTMENT PERIOD TRYING TO GET A FEEL FOR THE BB TUOHY & CATHETER. DESCRIPTION OF THE PATIENT EVENT - PATIENT HAD TO HAVE 2 CT SCANS DONE AND ENDED UP WITH A BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18913015 ↗
• MalfunctionMar 4, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: OUR ISSUE IS THAT THE CATHETER IS SEPARATING AT A POINT IN THE INTRO TO THE PATIENT WHERE IT CAN CAUSE HARM, SO THIS IS NOT ABOUT THE LACK OF CONNECTIVITY, IT IS ABOUT A PHYSICAL DEFECT WHERE THE CATHETER HAS BROKEN TWICE WHERE WE WERE TRYING TO INTRODUCE ANESTHESIA INTO A PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 18828256 ↗
• MalfunctionMar 4, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: OUR ISSUE IS THAT THE CATHETER IS SEPARATING AT A POINT IN THE INTRO TO THE PATIENT WHERE IT CAN CAUSE HARM, SO THIS IS NOT ABOUT THE LACK OF CONNECTIVITY, IT IS ABOUT A PHYSICAL DEFECT WHERE THE CATHETER HAS BROKEN TWICE WHERE WE WERE TRYING TO INTRODUCE ANESTHESIA INTO A PATIENT. FROM THE PROVIDER REGARDING ONE OF THE DEVICE FAILURES: "EASY EPIDURAL PLACEMENT. WAS THREADING THE CATHETER THROUGH THE TUOHY NEEDLE, THE PATIENT HAD SOME SUDDEN PARESTHESIAS AND THEN I MET SOME RESISTANCE WHEN I TRIED TO THREAD IT MORE. I STOPPED, TRIED PULLING THE CATHETER BACK THROUGH THE NEEDLE BUT MET A LOT OF RESISTANCE. CATHETER WAS STUCK EVEN WITH PULLING FORCEFULLY, SO I HAD TO PULL THE NEEDLE AND CATHETER OUT AS 1 UNIT. RE DID EPIDURAL AT SAME LEVEL WITH DIFFERENT CATHETER AND NEEDLE: NO ISSUE 1ST CATHETER HAD A FRACTURE IN IT". NO INJURY REPORTED.

  Patient problems: Paresthesia

  MAUDE report 18828200 ↗
• MalfunctionFeb 23, 2024Material Deformation; Material Deformation

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: THERE WAS AN INCIDENT WHERE AN EPIDURAL CATHETER WAS STUCK IN A PATIENT. DETAILED INQUIRY DESCRIPTION: THERE WAS AN INCIDENT WHERE AN EPIDURAL CATHETER - ITEM# 332079 (LOT# 0061907135 2025-04-30) WAS USED ON A PATIENT THAT LATER REQUIRED FURTHER DIAGNOSTICS (X-RAY, CT SCAN) PRIOR TO REMOVING THE CATHETER IN THE (B)(6) DEPARTMENT BECAUSE THE CATHETER KINKED/LOOPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766499 ↗
• MalfunctionJan 12, 2024Break; Break

  AS REPORTED PER MEDWATCH NUMBER MW5149366: "NESTHESIOLOGIST WAS INSERTING AN EPIDURAL CATHETER FOR PATIENT. ANESTHESIOLOGIST ATTEMPTED PLACEMENT AND PULLED THE CATHETER BACK OUT. THE BLUE CATHETER TIP WAS NOT INTACT AND THE WIRES WERE FRAYED. ANESTHESIOLOGIST NOTIFIED THE PATIENT THAT SHE WILL NEED TO HAVE AN MRI AFTER DELIVERY DUE TO POSSIBLE RETAINED METAL IN HER BACK. PATIENT IS A 32 YEAR-OLD, FIRST PREGNANCY AT 38 WEEKS, 6 DAYS, WITH ESTIMATED DATE OF DELIVERY: (B)(6) 2023. ADMITTED OVERNIGHT FOR LABOR. NOW COMFORTABLE WITH EPIDURAL. EPIDURAL WAS ATTEMPTED TWICE; AT FIRST INSERTION THE EPIDURAL TIP WAS POSSIBLY RETAINED IN THE PATIENT. ALLERGIC TO SULFA"

  Patient problems: Foreign Body In Patient

  MAUDE report 18509034 ↗
• MalfunctionAug 29, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF DESCRIPTION - MISSING NEEDLE TIP. ANESTHESIA REPORTED THAT THE NURSE CALLED TO SAY THE PT WAS TOSSING AND TURNING DURING THE NIGHT WITH DISCOMFORT. ANESTHESIA WENT TO REMOVE THE EPIDURAL FROM PATIENT, 3 MM LET INSIDE AND IT WAS DISLODGED FROM THE SITE. WHEN THEY PULLED IT OUT THE NEEDLE TIP WAS MISSING. ONCE REMOVED THE PATIENT HAD NO DISCOMFORT. JUST THE SURGICAL SITE.

  Patient problems: Discomfort

  MAUDE report 17641042 ↗
• MalfunctionFeb 22, 2023Break; Break

  AS REPORTED PER MEDWATCH NUMBER MW5114572: PLASTIC EPIDURAL CATHETER TIP BROKE OFF OF THE CATHETER WHILE INSIDE PT DURING PLACEMENT PROCEDURE BY ANESTHESIOLOGIST. PLASTIC TIP WAS NOT PRESENT WHEN CATHETER WAS REMOVED FROM THE PT'S BACK. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16418746 ↗
• MalfunctionJan 24, 2023Break; Break

  PER MEDWATCH NUMBER MW5114168: DESCRIPTION: THE PT UNDERWENT PLACEMENT OF AN EPIDURAL CATHETER. CATHETER WAS ADVANCED WITH EASE UNTIL JUST BEYOND THE 15 CM MARK, UPON WHICH ADVANCEMENT OF THE CATHETER WAS MET WITH RESISTANCE. CATHETER FOUND TO BE ENTRAPPED IN ITS POSITION AS ITS SUBSEQUENT REMOVAL WAS MET WITH FIRM RESISTANCE. ATTEMPTED TO WITHDRAWAL CATHETER SLOWLY, HOWEVER UPON REMOVAL OF CATHETER, TIP WAS NOT FOUND INTACT, 4 CM OF THE CATHETER TIP IS RETAINED IN THE PT'S BACK.

  Patient problems: Foreign Body In Patient

  MAUDE report 16237364 ↗
• MalfunctionJun 7, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE EPIDURAL CATHETER RETRACTED WITH TIP NOT INTACT. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14618794 ↗
• MalfunctionMar 29, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: DETAIL: IT WAS REPORTED THAT VARIOUS PHYSICIANS ENCOUNTERED PROBLEMS WITH THE CATHETER KNOTTING UP DURING PLACEMENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13944792 ↗
• MalfunctionMar 29, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAIL: IT WAS REPORTED THAT VARIOUS PHYSICIANS ENCOUNTERED PROBLEMS WITH THE CATHETER KNOTTING UP DURING PLACEMENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13944694 ↗