Perifix® 332097 (UDI 04046964177361)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 04046964177361), received between Nov 21, 2016 and Oct 23, 2025 — classified as 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Break; Break

  AS REPORTED VIA MEDWATCH NUMBER MW5176020: DESCRIBE EVENT OR PROBLEM: DURING EPIDURAL CATHETER REMOVAL, APPROXIMATELY 3.5 CM OF CATHETER TIP WAS MISSING. NO REPORTED HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367507 ↗
• MalfunctionAug 7, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CATHETER TIP BROKE OFF INTO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22739803 ↗
• MalfunctionNov 5, 2024Device Alarm System; Device Alarm System

  AS REPORTED, AIR IN LINE. FREQUENTLY BEEPS FOR BUBBLES. NO BUBBLES DETECTED WHEN LINE EXAMINED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 20609740 ↗
• MalfunctionNov 5, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363904, LOT: UNKNOWN) WAS BEING USED TO ADMINISTER MILRINONE AT 9.6 MILLILITERS (ML) PER HOUR ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PUMP REPEATEDLY DETECTED AIR IN LINE DESPITE BOTH MANUAL PRIMING AND PRIMING THROUGH THE PUMP. ADDITIONALLY, THE IV TUBING WAS REMOVED AND RELOADED TO ENSURE PROPER LOADING. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609074 ↗
• MalfunctionNov 5, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED, AIR IN LINE ALARM. TUBING IN A NEW SET. RE-PRIMED THRU PUMP ASV VALVE ON-THEN TO AMIODUENE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608803 ↗
• MalfunctionNov 5, 2024Break; Break

  AS REPORTED BY USER FACILITY: IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT A PERIFIX EPIDURAL CATHETER (MATERIAL 332097, LOT 0061944517) WAS BEING USED FOR PAIN MANAGEMENT DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, RESISTANCE WAS ENCOUNTERED DURING THE PLACEMENT OF THE EPIDURAL CATHETER, WHICH PREVENTED FURTHER ADVANCEMENT. THE DECISION WAS MADE TO REMOVE THE CATHETER, BUT IT FELT LODGED. AFTER WITHDRAWING THE WHOLE EPIDURAL NEEDLE, RESISTANCE WAS AGAIN ENCOUNTERED WHILE ATTEMPTING TO EXTRACT THE REMAINDER OF THE CATHETER. THE CATHETER TIP COULD NOT BE VISUALIZED, INDICATING THAT A PORTION HAD BROKEN OFF AND REMAINED IN THE PATIENT'S LUMBAR REGION. UPON INSPECTION, APPROXIMATELY 15 CENTIMETERS (CM) OF THE CATHETER HAD DETACHED AND WAS RETAINED IN THE PATIENT. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20608702 ↗
• MalfunctionJun 25, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION 0061926202 - ELMWOOD, 0061923788 - BAPTIST. HEY (B)(6), ABOVE ARE THE TWO LOT NUMBERS FOR THE CATHETER TRAYS WE DISCUSSED YESTERDAY. I AM STILL TRYING TO GET THE LOT NUMBER FROM MAIN CAMPUS. JUST AS A REFRESHER - WE HAVE HAD 4 INSTANCES IN THE PAST TWO WEEKS OF EPIDURAL CATHETERS GETTING "STUCK" DURING THE REMOVAL PROCESS. ON THREE OF THOSE OCCASIONS, THE PLASTIC COVERING EVENTUALLY SHEARED, AND VARYING AMOUNTS WERE POSSIBLY LEFT IN THE PATIENT. I CAN SPEAK TO THE REMOVAL I WAS A PART OF, AND IT SEEMED LIKE THE SPRINGWOUND COIL WAS FULLY REMOVED, BUT THE LAST 2-3 CM WAS SHEARED OFF AND NOT PRESENT. ON THE FOURTH OCCASION, THE CATHETER WAS ABLE TO BE REMOVED BUT THE BLUE TIP WAS NOT PRESENT, AND IT WAS UNCLEAR AS TO WHETHER THE CATHETER WAS SHEARED OR IF THE BLUE COLOR HAD SIMPLY WORN OFF FROM THE TIP. AS I CONTINUE TO DISCUSS THIS ISSUE WITH ADDITIONAL STAFF, ALMOST ALL SEEM TO AGREE THAT THEY FEEL THERE HAS BEEN A NOTICEABLE DIFFERENCE IN CATHETER QUALITY OVER THE PAST FEW MONTHS, AT LEAST.

  Patient problems: Foreign Body In Patient

  MAUDE report 19605450 ↗
• MalfunctionJun 25, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2 DETAILED INQUIRY DESCRIPTION 0061926202 - ELMWOOD. 0061923788 - BAPTIST. HEY (B)(6), ABOVE ARE THE TWO LOT NUMBERS FOR THE CATHETER TRAYS WE DISCUSSED YESTERDAY. I AM STILL TRYING TO GET THE LOT NUMBER FROM MAIN CAMPUS. JUST AS A REFRESHER - WE HAVE HAD 4 INSTANCES IN THE PAST TWO WEEKS OF EPIDURAL CATHETERS GETTING "STUCK" DURING THE REMOVAL PROCESS. ON THREE OF THOSE OCCASIONS, THE PLASTIC COVERING EVENTUALLY SHEARED, AND VARYING AMOUNTS WERE POSSIBLY LEFT IN THE PATIENT. I CAN SPEAK TO THE REMOVAL I WAS A PART OF, AND IT SEEMED LIKE THE SPRINGWOUND COIL WAS FULLY REMOVED, BUT THE LAST 2-3 CM WAS SHEARED OFF AND NOT PRESENT. ON THE FOURTH OCCASION, THE CATHETER WAS ABLE TO BE REMOVED BUT THE BLUE TIP WAS NOT PRESENT, AND IT WAS UNCLEAR AS TO WHETHER THE CATHETER WAS SHEARED OR IF THE BLUE COLOR HAD SIMPLY WORN OFF FROM THE TIP. AS I CONTINUE TO DISCUSS THIS ISSUE WITH ADDITIONAL STAFF, ALMOST ALL SEEM TO AGREE THAT THEY FEEL THERE HAS BEEN A NOTICEABLE DIFFERENCE IN CATHETER QUALITY OVER THE PAST FEW MONTHS, AT LEAST.

  Patient problems: Foreign Body In Patient

  MAUDE report 19605448 ↗
• MalfunctionJun 25, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2 DETAILED INQUIRY DESCRIPTION 0061926202 - ELMWOOD 0061923788 - BAPTIST HEY HELGA, ABOVE ARE THE TWO LOT NUMBERS FOR THE CATHETER TRAYS WE DISCUSSED YESTERDAY. I AM STILL TRYING TO GET THE LOT NUMBER FROM MAIN CAMPUS. JUST AS A REFRESHER - WE HAVE HAD 4 INSTANCES IN THE PAST TWO WEEKS OF EPIDURAL CATHETERS GETTING "STUCK" DURING THE REMOVAL PROCESS. ON THREE OF THOSE OCCASIONS, THE PLASTIC COVERING EVENTUALLY SHEARED, AND VARYING AMOUNTS WERE POSSIBLY LEFT IN THE PATIENT. I CAN SPEAK TO THE REMOVAL I WAS A PART OF, AND IT SEEMED LIKE THE SPRING WOUND COIL WAS FULLY REMOVED, BUT THE LAST 2-3 CM WAS SHEARED OFF AND NOT PRESENT. ON THE FOURTH OCCASION, THE CATHETER WAS ABLE TO BE REMOVED BUT THE BLUE TIP WAS NOT PRESENT, AND IT WAS UNCLEAR AS TO WHETHER THE CATHETER WAS SHEARED OR IF THE BLUE COLOR HAD SIMPLY WORN OFF FROM THE TIP. AS I CONTINUE TO DISCUSS THIS ISSUE WITH ADDITIONAL STAFF, ALMOST ALL SEEM TO AGREE THAT THEY FEEL THERE HAS BEEN A NOTICEABLE DIFFERENCE IN CATHETER QUALITY OVER THE PAST FEW MONTHS, AT LEAST.

  Patient problems: Foreign Body In Patient

  MAUDE report 19605408 ↗
• MalfunctionJun 25, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1 DETAILED INQUIRY DESCRIPTION: 0061926202 - ELMWOOD, 0061923788 - BAPTIST. HEY (B)(6), ABOVE ARE THE TWO LOT NUMBERS FOR THE CATHETER TRAYS WE DISCUSSED YESTERDAY. I AM STILL TRYING TO GET THE LOT NUMBER FROM MAIN CAMPUS. JUST AS A REFRESHER - WE HAVE HAD 4 INSTANCES IN THE PAST TWO WEEKS OF EPIDURAL CATHETERS GETTING "STUCK" DURING THE REMOVAL PROCESS. ON THREE OF THOSE OCCASIONS, THE PLASTIC COVERING EVENTUALLY SHEARED, AND VARYING AMOUNTS WERE POSSIBLY LEFT IN THE PATIENT. I CAN SPEAK TO THE REMOVAL I WAS A PART OF, AND IT SEEMED LIKE THE SPRINGWOUND COIL WAS FULLY REMOVED, BUT THE LAST 2-3 CM WAS SHEARED OFF AND NOT PRESENT. ON THE FOURTH OCCASION, THE CATHETER WAS ABLE TO BE REMOVED BUT THE BLUE TIP WAS NOT PRESENT, AND IT WAS UNCLEAR AS TO WHETHER THE CATHETER WAS SHEARED OR IF THE BLUE COLOR HAD SIMPLY WORN OFF FROM THE TIP. AS I CONTINUE TO DISCUSS THIS ISSUE WITH ADDITIONAL STAFF, ALMOST ALL SEEM TO AGREE THAT THEY FEEL THERE HAS BEEN A NOTICEABLE DIFFERENCE IN CATHETER QUALITY OVER THE PAST FEW MONTHS, AT LEAST.

  Patient problems: Foreign Body In Patient

  MAUDE report 19605406 ↗
• MalfunctionJan 18, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: DURING INSERTION OF FX CATHETER IN TRAY 332097, CATHETER SHEARED. PHYSICIAN TRIED TO REMOVE AND TIP OF CATHETER SHEARED OFF IN PATIENT. ADDITIONAL INFORMATION RECEIVED: THE CATHETER FRAGMENT WAS NOT REMOVED. THEIR TEAM DECIDED TO KEEP IT IN PLACE AS IT WAS THE SAFEST APPROACH FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18535190 ↗
• MalfunctionOct 17, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: UPON REMOVAL OF THE EPIDURAL CATHETER FROM THE PATIENT'S LUMBAR, THE CRNA FELT RESISTANCE AND NOTICED ABOUT 11 CM OF THE CATHETER TIP WAS SHEARED OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 17948866 ↗
• MalfunctionOct 9, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BROKEN FX CATHETER IN PATIENT DETAILED INQUIRY DESCRIPTION: L&D PATIENT HAS PART OF FX CATHETER THAT HAS SHEARED OFF IN BACK. ONE OF THE PHYSICIANS WAS HAVING DIFFICULTY ADVANCING THE CATHETER INTO THE EPIDURAL SPACE SO THE NEEDLE AND THE CATHETER WERE BOTH REMOVED WITH THE INTENT OF RE-DIRECTING. UPON REMOVAL, THE END OF THE CATHETER WAS MISSING, AND THE WIRE WAS UNCOILED. A NEW EPIDURAL CATHETER HAD TO BE PLACED.

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

  MAUDE report 17895916 ↗
• MalfunctionOct 9, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: EPIDURAL CATHETER SHEARED. DETAILED INQUIRY DESCRIPTION: INCIDENT: UPON REMOVAL OF THE INITIAL PLACEMENT OF THE CATHETER, THE CATHETER SHEARED OFF. A CT SCAN OF THE LUMBAR WAS DONE. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17895262 ↗
• InjuryAug 30, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT OR PROBLEM: EPIDURAL CATHETER (PERIFIX FX SPRINGWOUND EPIDURAL CATHETER 19 GAUGES CLOSED TIP) WAS USED TO ENTER EPIDURAL SPACE ON A LABORING PATIENT. EPIDURAL SPACE WAS ENTERED THROUGH MIDLINE APPROACH WITHOUT TRAUMA. EPIDURAL CATHETER WAS THREADED THROUGH TOUHY NEEDLE BUT RESISTANCE WAS FELT AT THE 13-15CM MARK. ATTEMPTED TO READJUST NEEDLE AND TRIED TO ADVANCE CATHETER BUT MET WITH RESISTANCE AGAIN. DECISION WAS MADE TO COMPLETELY REMOVE CATHETER HOWEVER THERE WAS RESISTANCE WHEN ATTEMPTED TO REMOVE AND THE CATHETER APPEARED TO STRETCH. ATTEMPTED TO REMOVE TOUHY NEEDLE WITH CATHETER TOGETHER BUT ONCE TOUHY NEEDLE WAS OUT, 6CM OF CATHETER REMAINED IN SKIN. MULTIPLE ATTEMPTS MADE AND IN MULTIPLE DIFFERENT POSITIONS BUT UNABLE TO REMOVE CATH. THE FOLLOWING DAY OPTIONS PROVIDED TO PATIENT AND PATIENT REQUESTED TO HAVE THE CATHETER PULLED. DURING RETRACTION OF THE CATHETER A "PIECE BROKE OFF". GENERAL SURGERY CONSULTED TO PERFORM SMALL INCISION CUT DOWN WITH EXPLORATION OF DERMAL AND EPIDERMAL LAYER (PER CT IMAGING IMPRESSION) BUT WAS UNABLE TO LOCATE THE REMAINING CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15323703 ↗
• MalfunctionAug 22, 2022Break; Physical Resistance/Sticking

  EPIDURAL CATHETER (PERIFIX FX SPRINGWOUND EPIDURAL CATHETER 19 GAUGES CLOSED TIP) WAS USED TO ENTER EPIDURAL SPACE ON A LABORING PATIENT. EPIDURAL SPACE WAS ENTERED THROUGH MIDLINE APPROACH WITHOUT TRAUMA. EPIDURAL CATH WAS THREADED THROUGH TUOHY NEEDLE BUT RESISTANCE WAS FELT AT THE 13-15CM MARK. ATTEMPTED TO READJUST NEEDLE AND TRIED TO ADVANCE CATH BUT MET WITH RESISTANCE AGAIN. DECISION WAS MADE TO COMPLETELY REMOVE CATH HOWEVER THERE WAS RESISTANCE WHEN ATTEMPTED TO REMOVE AND THE CATH APPEARED TO STRETCH. ATTEMPTED TO REMOVE TUOHY NEEDLE WITH CATH TOGETHER BUT ONCE TUOHY NEEDLE WAS OUT, 6CM OF CATH REMAINED IN SKIN. MULTIPLE ATTEMPTS MADE AND IN MULTIPLE DIFFERENT POSITIONS BUT UNABLE TO REMOVE CATH. THE FOLLOWING DAY OPTIONS PROVIDED TO PATIENT AND PATIENT REQUESTED TO HAVE THE CATHETER PULLED. DURING RETRACTION OF THE CATH A "PIECE BROKE OFF". GENERAL SURGERY CONSULTED TO PERFORM SMALL INCISION CUT DOWN WITH EXPLORATION OF DERMAL AND EPIDERMAL LAYER (PER CT IMAGING IMPRESSION) BUT WAS UNABLE TO LOCATE THE REMAINING CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15264685 ↗
• MalfunctionJul 27, 2022Break; Break

  (B)(6) REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE OBSTETRIC PATIENT HAD A CONTRACTION DURING PLACEMENT OF THE EPIDURAL CATHETER. THE ANESTHESIOLOGIST BELIEVES THE TIP OF THE CATHETER SHEARED OFF DURING THE CONTRACTION. THE PATIENT HAS HAD AN MRI WHICH SHOWS METALLIC ARTIFACT. THEY ARE LEAVING THE TIP IN PLACE FOR NOW AND WILL CONTINUE TO MONITOR HER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15111094 ↗
• MalfunctionJun 7, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT BLEEDING OCCURRED FROM THE TUOHY NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622927 ↗
• MalfunctionJun 7, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT BLEEDING OCCURRED FROM THE TUOHY NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622918 ↗
• MalfunctionJun 7, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT BLEEDING OCCURRED FROM THE TUOHY NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622831 ↗
• MalfunctionJun 7, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT BLEEDING OCCURRED FROM THE TUOHY NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622740 ↗
• MalfunctionDec 7, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: EPIDURAL CATHETER KNOTTED AT THE PROXIMAL END UPON REMOVAL. CRNA NOTICED IT WAS DIFFICULT TO PUSH MEDS BUT IT STILL WORKED. INSERTION NOT DIFFICULT. CATHETER REMOVED BY NURSE, DIFFICULT TO REMOVE BUT NO COMPLICATIONS REPORTED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12956946 ↗
• MalfunctionAug 25, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: PER MEDWATCH FORM MW5102773: "EPIDURAL CATHETER PLACED FOR PAIN MANAGEMENT FOR LABOR (B)(6) 2021. UPON REMOVAL, THE CATHETER WAS FRACTURED WITH 2 CM OF THE CATHETER REMAINING IN THE PATIENT'S SPINE. NEURO SURGEON CONSULTED AND RECOMMENDED FOR RETAINED CATHETER FRAGMENT TO REMAIN."

  Patient problems: Foreign Body In Patient

  MAUDE report 12364284 ↗
• MalfunctionMay 28, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING REMOVAL OF THE CATHETER, THE TIP WAS MISSING. NURSE STATED THERE WAS NO RESISTANCE PUTTING THE CATHETER IN OR REMOVING THE CATHETER. NO INTERVENTION WAS PERFORMED TO REMOVE THE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 10097305 ↗
• MalfunctionAug 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, "CATHETER SLIDING OUT OF CLOSED CATHETER CONNECTOR". NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8942836 ↗