Perifix® 332220Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04046964178320), received between Nov 7, 2017 and Aug 13, 2024 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Break; Break

  AS DESCRIBED IN MW5156758: DESCRIBE EVENT OR PROBLEM: APPROXIMATELY 5CM OF CATHETER TIP WAS SHEARED OFF IN PATIENT'S SPINAL COLUMN DURING EPIDURAL CATHETER PLACEMENT REQUIRING MULTIPLE IMAGING STUDIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 19973222 ↗
• MalfunctionMay 3, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: AFTER THE PATIENT HAD GIVEN BIRTH TO HER CHILD, WHEN REMOVING EPIDURAL CATHETER THERE WAS 3 INCHES MISSING. AN X-RAY & CT SCAN DONE TO RULE OUT BEING LEFT BEHIND IN PATIENT. NEITHER SCAN SHOWED ANYTHING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864634 ↗
• MalfunctionApr 21, 2023Malposition of Device; Malposition of Device

  AS REPORTED BY THE USER FACILITY, MIDAS EVENT 23-9924 - HIGH SPINAL DURING ROUTINE EPIDURAL   WORKING WITH LABOR AND DELIVERY, CLINICAL OPERATIONS, AND VENDOR FOR RETURN AND REVIEW OF CATHETERS BY B BRAUN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Reaction to Medicinal Component of Device

  MAUDE report 16791621 ↗
• MalfunctionMar 21, 2023Material Deformation; Material Deformation

  AS REPORTED BY THE USER FACILITY: PERIFIX EPIDURAL KIT USED. PATIENT CONSENTED FOR LABOR EPIDURAL. POSITIONED SITTING, LOSS OF RESISTANCE TECHNIQUE WITH SYRINGE PROVIDED IN KIT. SALINE DRAWN UP INTO LOR SYRINGE, ATTACHED TO EPIDURAL NEEDLES, INITIALLY WORKING APPROPRIATELY, EPIDURAL NEEDLE ADVANCED WITH CONTINUOUS PRESSURE. RESISTANCE TO ADVANCEMENT NOTED AT LIKELY LIGAMENTUM FLAVUM. ATTEMPTED LOR NEGATIVE. ADVANCED SLIGHTLY, NEGATIVE LOR. SYRINGE REMOVED AND RETURNED OF FREE FLOW OF CLEAR FLUID SEEN FROM EPIDURAL NEEDLE (LIKELY CSF). SYRINGE REPLACED, STILL NO ABILITY TO INJECT SALINE. EPIDURAL REMOVED. SYRINGE INSPECTED AND FOUND TO HAVE BECOME SEIZED UP WHERE PLUNGE CONTACTS SIDE OF GLASS SYRINGE. UNABLE TO EITHER WITHDRAW OR ADVANCE PLUNGER. PATIENT INFORMED OF DURAL PUNCTURE, AND PROCEDURE REPEATED USING A DIFFERENT EPIDURAL TRAY WITHOUT DIFFICULT. WILL LIKELY RESULT IN PDPH AND NEED FOR THERAPEUTIC EPIDURAL BLOOD PATCH. PATIENT'S MEDICAL CONDITION: EPIDURAL FOR LABOR. EXTENT OF INJURY: DURAL PUNCTURE, B. NATURE OF INTERVENTION: EPIDURAL BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 16582512 ↗
• MalfunctionOct 19, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT DURING A BIRTH (POSSIBLY A C-SECTION), THE CATHETER IN THE CONTINUOUS EPIDURAL TRAY WAS KNOTTED DURING INSERTION INTO THE PATIENT BUT WAS NOT OBVIOUS AT ADMINISTRATION (WAS NOT NOTED PRIOR TO PLACEMENT). AS THE MEDICAL STAFF COULD NOT REMOVE THE TUOHY NEEDLE NOR WERE THEY ABLE TO INJECT THROUGH THE CATHETER, THEY REMOVED THE CATHETER AND THE NEEDLE TOGETHER AND NOTICED A KNOT IN THE CATHETER. THE STAFF GRABBED ANOTHER PRODUCT FROM THE EXACT SAME TRAY, AND IT WORKED FINE. TO THE REPORTER'S KNOWLEDGE THERE WERE NO COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE DUE TO THE REPORTED DEVICE MALFUNCTION NOR WAS ANY MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633907 ↗
• MalfunctionSep 2, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: END USER REPORTS, "UPON INSERTION OF THE CATHETER THE TIP WAS SHEARED OFF AND REMAINS IN THE PATIENT. THE PATIENT WILL BE GOING FOR A STAT CT SCAN TO DETERMINE FURTHER MANAGEMENT/INTERVENTIONS THAT ARE NEEDED." NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12419045 ↗
• MalfunctionJun 1, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT AN EPIDURAL WAS PLACED FOR LABOR AND AS THE EPIDURAL CATHETER WAS BEING TAPED DOWN, IT SNAPPED OFF. THERE WAS A PIECE REMAINING IN THE PATIENT. THEY WERE ABLE TO SUCCESSFULLY REMOVE THE PIECE WITH A TWEEZERS. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10105963 ↗
• InjuryApr 8, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN THE CRNA (CERTIFIED REGISTERED NURSE ANESTHETISTS) ATTEMPTED TO START THE EPIDURAL AND WAS UNSUCCESSFUL. WHEN THE NURSE TRIED AGAIN TO START THE EPIDURAL, THE NURSE STATED THAT A FOUR (4) INCH SEGMENT OF THE CATHETER BROKE OFF INTO THE PATIENT'S THIRD LUMBAR VERTEBRA EPIDURAL SPACE.

  Patient problems: Disability; Foreign Body In Patient; Pain

  MAUDE report 9935630 ↗
• MalfunctionFeb 17, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING REMOVAL OF THE CATHETER, THE CATHETER TIP BROKE. A CT SCAN WAS PERFORMED AND THE TIP WAS NOT VISIBLE.

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

  MAUDE report 9716755 ↗
• MalfunctionSep 24, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A CATHETER WAS BEING REMOVED ON A PATIENT AFTER A VAGINAL DELIVERY UNDER NORMAL CONDITIONS. WHEN THE CATHETER WAS REMOVED, IT WAS NOTICED THAT APPROXIMATELY 3 CM OF THE TIP REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9112721 ↗
• MalfunctionJul 18, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS CATHETER RETAINED IN PATIENT. IT WAS STATED THAT THE CATHETER WAS PLACED ABOUT NOON ON (B)(6) 2019 AND REMOVED ABOUT 5:30 PM AND THE TIP WAS NOTED TO BE MISSING. END USER BELIEVES THAT ABOUT 5MM OF THE TIP RETAINED IN PATIENT. IT LOOKS LIKE THE CATHETER BROKE AT THE LOWEST OPENING. NO SIGNS AND SYMPTOMS OF ANY ISSUE WITH RETAINED PIECE OF CATHETER. AT THIS TIME THEY ARE NOT PLANNING ON REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 8802418 ↗
• MalfunctionJul 18, 2019Break; Break

  AS PER MEDWATCH NUMBER: (B)(4). EPIDURAL INSERTED FOR SURGERY. UPON REMOVING CATHETER AFTER CASE IT WAS DISCOVERED THE BLUE TIP WAS NOT INTACT. DISCUSSED WITH RADIOLOGIST AND RECOMMENDED LUMBER FILMS AND CT. 7MM OF EPIDURAL CATHETER FOUND AT L1-2 IN EPIDURAL SPACE. DISCUSSED CASE WITH NEUROSURGERY AFTER CT REVIEWED STATED NO INTERVENTION NEEDED. DISCUSSED WITH PT IN DETAIL AND ADVISED PATIENT TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN (PCP) SHOULD SHE BECOME SYMPTOMATIC. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8802415 ↗
• MalfunctionJul 11, 2019Break; Break

  AS PER MEDWATCH NUMBER (B)(4): PATIENT PRESENTED IN LABOR. AN EPIDURAL BLOCK WAS PERFORMED FOR LABOR ANALGESIA. THE CATHETER WAS INSERTED WITH OUT DIFFICULTY. AFTER THE NEWBORN WAS DELIVERED, THE CATHETER WAS ATTEMPTED TO BE REMOVED, BUT THE ANESTHESIOLOGIST MET RESISTANCE. HE HAD THE PATIENT LEAN FORWARD IN HOPES TO DISLODGE THE CATHETER, BUT IT BROKE. NEUROSURGERY WAS CALLED AND THE PATIENT OPTED TO HAVE THE BROKEN PIECE OF CATHETER SURGICALLY REMOVED. A CT SCAN REVEALED THAT THE BROKEN PIECE OF CATHETER WAS BETWEEN THE L4 AND L5 AND WAS MIDLINE IN THE LAMINA. THE SURGEON NOTED THAT THE CATHETER WAS TIGHT BETWEEN THE BONES AND SOME PORTION OF THE BONE NEEDED TO BE REMOVED IN ORDER TO FREE THE CATHETER. APPROXIMATELY 6CM PIECE OF CATHETER WAS REMOVED FROM THE PATIENT. SHE RECOVERED WITHOUT INCIDENT AND WAS DISCHARGED HOME ON POST-PARTUM DAY 2.

  Patient problems: Foreign Body In Patient

  MAUDE report 8781003 ↗
• MalfunctionJun 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: THE PATIENT WAS REPORTING INCREASED PAIN, WHEN THE NURSE WENT TO ASSESS THE CATHETER IT WAS DISCOVERED THE CATHETER WAS DISCONNECTED FROM THE CLAMP. EPIDURAL BECAME DISCONNECTED BETWEEN THE THIN EPIDURAL CATHETER AND CLAMP THAT CONNECTS TO THE EPIDURAL TUBING. THE CATHETER CAME OUT OF THE CONNECTOR BUT NOT THE PATIENT. THE NURSE BLOUSED THE PATIENT'S EPIDURAL IN ATTEMPTS TO GET HER COMFORTABLE AGAIN. THE CATHETER CONTINUED TO BE USED. NO INJURY REPORTED.

  Patient problems: Pain

  MAUDE report 8726276 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY VIA A LETTER INCLUDING MW5085631: PATIENT'S EPIDURAL CATHETER WAS FOUND TO COME APART FROM THE TUBING AT THE CONNECTOR. THE JUNCTION HAD BEEN PREVIOUSLY TAPED AS A WORKAROUND. THE EPIDURAL HAD TO BE REMOVED AND PAIN WAS MANAGED BY THE PRIMARY SERVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574338 ↗
• MalfunctionFeb 21, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE 20G POLYAMIDE CATHETER SNAPPED IN HALF DURING USE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8359507 ↗
• MalfunctionFeb 21, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE 20G POLYAMIDE CATHETER SNAPPED IN HALF DURING USE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8359501 ↗
• InjuryDec 11, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: AN ISSUE OCCURED DURING REMOVAL OF THE EPIDURAL CATHETER. PATHOLOGY EXAMINATION DETERMINED THE TIP TO BE INTACT; HOWEVER, THERE WAS ABOUT 2-3 MM OF CLEAR TUBING EXTENDING BEYOND THE BLUE TIP MARKING. A CT SCAN WAS CONDUCTED AND NOTHING WAS OBSERVED. PATIENT HAD NO SIGNS OR SYMPTOMS RELATED TO THE RETAINED CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 8150974 ↗
• MalfunctionApr 21, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER TIP BROKE OFF. PATIENT WAS PLACED IN THE SITTING POSITION WITH MATERNAL AND FETAL MONITORING. AFTER IDENTIFYING THE L4-L5 INTER-SPACED BASED ON ANATOMIC LANDMARKS, THE SKIN WAS STERILELY PREPPED USING CHLORHEXIDINE AND ALLOWED TO DRY PRIOR TO STERILE DRAPING. STRICT STERILE TECHNIQUE WAS MAINTAINED THROUGHOUT, INCLUDING THE USE OF A CAP, A MASK, A STERILE FENESTRATED DRAPE, AND STERILE GLOVES. THE SKIN AND SUBCUTANEOUS TISSUE WERE ANESTHETIZED WITH 1% LIDOCAINE. AN 18-GAUGE 3-1/2 INCH EPIDURAL TIPPED NEEDLE WAS ADVANCED INTO THE EPIDURAL SPACE FROM A MIDLINE AFTER 1 ATTEMPT. LOSS OF RESISTANCE TO PRESERVATIVE-FREE SALINE WAS ACHIEVED AT 6 CM. A MULTIORIFICE CATHETER WAS INSERTED TO < 10CM AND RESISTANCE WAS MET. THEN ROTATED NEEDLE 90 DEGRESS TO THE RIGHT AND ATTEMPTED TO ADVANCE CATHETER AND STILL MET RESISTANCE. CATHETER WAS THEN WITHDRAWN AT THAT TIME AND THE BLUE TIP WAS NOT INTACT. PATIENT HAD AN XRAY AND CT AND NEITHER SHOWED ANY EVIDENCE OF RETAINED FOREIGN BODY. THE RESULTS WERE OVERREAD BY NEUROSURGERY AS WELL, AND THEY DID NOT SEE EVIDENCE OF RETAINED FOREIGN BODY. NO REPORTED PATIENT STATUS CHANGE AT THI

  Patient problems: Foreign Body In Patient

  MAUDE report 7449671 ↗
• MalfunctionNov 7, 2017Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER SHEARED IN PATIENT. SHEARING OCCURRED DURING PLACEMENT. THE MD DOCUMENTED THAT THEY ENCOUNTERED SOME RESISTANCE WHILE ENTERING THE EPIDURAL SPACE. ATTEMPTED TO ADJUST THE CATHETER, WITH THE NEEDLE STILL IN PLACE, BY PULLING IT BACK, ENCOUNTERED MORE RESISTANCE BEFORE THE RESISTANCE WAS RELIEVED. UPON REMOVING THE CATHETER AND NEEDLE IT WAS THEN DISCOVERED THAT 6.5 CM OF THE CATHETER HAD BROKEN OFF AND RETAINED IN THE PATIENT. PATIENT HAS NO SIGNS AND SYMPTOMS RELATED TO THE RETAINED CATHETER. NEUROSURGERY CONSULTATION DUE TO THE RETAINED CATHETER. PATIENT DOES CONTINUE TO HAVE RETAINED CATHETER WITH NO PLANS FOR REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7008212 ↗
• MalfunctionNov 7, 2017Break; Break

  AS REPORTED BY THE USER FACILITY: REPORTS STATES THAT DURING AN ATTEMPT TO PLACE AN EPIDURAL, THE CATHETER TIP BROKE OFF INSIDE THE PATIENT. DOCTOR STATED SHE ATTEMPTED TO THREAD CATHETER IN EPIDURAL SPACE, FELT RESISTANCE. SHE WASN'T SURE IF SHE HAD RESISTANCE BECAUSE SHE WAS NEAR BONE OR IF THE CATHETER CAUSED. SHE WENT TO REMOVE TOUGHEY NEEDLE AND CATHETER OUT TOGETHER AND HAD RESISTANCE AGAIN. AT THAT POINT, SHE FELT A POP OR SNAP. DOCTOR IMMEDIATELY LOOKED AT TIP OF THE CATHETER AND SAW THE BLUE TIP HAD BROKEN OFF INTO THE PATIENT. BEING THAT THE PATIENT WAS IN LABOR, THE DOCTOR THEN STARTED ANOTHER EPIDURAL IN SPACE BELOW INITIAL AND THAT ONE WAS PLACED SUCCESSFULLY, PATIENT DELIVERED THE BABY SUCCESSFULLY. PATIENT HAD CAT SCAN AND MRI IMMEDIATELY AFTER GIVING BIRTH AND THE CATHETER TIP WAS NOT LOCATED. NEUROSURGERY WAS CONSULTED. NEUROSURGERY RECOMMENDED NO MEDICAL INTERVENTION. PATIENT WAS NOTIFIED IMMEDIATELY AT TIME INCIDENT OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7008209 ↗