BD Perisafe 400273Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00382904002732), received between Mar 27, 2018 and Aug 27, 2025 — classified as 10 injuries, 23 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Leak/Splash; Leak/Splash

  IT IS REPORTED LEAKAGE. EVENT DESCRIPTION: AFTER INSERTING THE CATHETER LEAKAGE FOUND IN THE DRESSING. ADDITIONAL INFORMATION: NO PATIENT WERE INFECTED. LEAKAGE WILL AFFECT THE DOSAGE AND ACTION OF DRUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903094 ↗
• MalfunctionJun 27, 2025Defective Component; Defective Component

  IT SEEMED AS IF THERE WAS ONLY ONE HOLE OPEN IN THE CATHETER, EVENT DETAILS: RECEIVED AN EPIDURAL CATHETER DURING LABOR. IN THE DELIVERY ROOM, THE PUMP INDICATES OCCLUSION PRESSURE AFTER APPROXIMATELY 6 ML HAS BEEN ADMINISTERED. THIS HAPPENS SEVERAL TIMES BEFORE I AM CALLED AS AN APS NURSE. VISUALLY, THERE IS NO KINK IN THE PUMP TUBE OR CATHETER. BECAUSE WE USE 3.00 M LINES, OCCLUSION PRESSURE OCCASIONALLY OCCURS. THEREFORE, A SHORTER PUMP TUBE (2.00 M) WAS CONNECTED, BUT WITHOUT RESULT. THE SYRINGE WAS THEN CHANGED WITHOUT RESULT, THE PUMP WAS CHANGED WITHOUT RESULT, AND THE FILTER WAS REPLACED WITHOUT RESULT. THE CATHETER WAS THEN WITHDRAWN 2 CM, BUT THAT DID NOT HELP EITHER. UNFORTUNATELY, THE EPIDURAL WAS CONSIDERED ¿LOST¿. AFTER REMOVING THE EPIDURAL CATHETER, I RECEIVED THE CATHETER AND EXAMINED IT: THERE WAS NO KINK IN THE CATHETER ANYWHERE. THE CATHETER WAS CONNECTED TO THE PUMP (OUTSIDE THE PATIENT) AND THE PUMP STILL GAVE AN OCCLUSION ALARM. FLUSHING BY HAND WAS ALSO ALMOST IMPOSSIBLE: IT SEEMED AS IF THERE WAS ONLY ONE HOLE OPEN IN THE CATHETER: ON THE CATHETER, A FEW MILLIMETERS FROM THE TIP, ONLY ONE DROP CAME OUT OF THE CATHETER. HAS THERE BEEN ANY PATIENT IMPACT (SER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347241 ↗
• MalfunctionMar 25, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689247 ↗
• InjuryAug 13, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19973185 ↗
• InjuryAug 6, 2024Break; Break

  DEAR SIR, MADAM. IT HAS BEEN THREE WEEKS AGO THAT WE CONTACTED YOU CONCERNING THE MATERIAL USED IN THE BD EPIDURAL CATHETER, 20 GAUGE CLOSED END (FOR USE WITH THE 3.5" BD EPIDURAL NEEDLE) - X12938. ON 9 JULY 2024, I WAS INFORMED TEAM HAS SENT THE REQUEST TO THE PRODUCT STEWARDSHIP TEAM ([email protected]). HOWEVER, WE HAVE NOT YET RECEIVED A RESPONSE: ALSO, NOT AFTER SENDING (REMINDER) E-MAILS ON 16-7-2024 (TO [email protected]). THEREFORE, I AM E-MAILING ONCE AGAIN TO REQUEST TO YOU TO INFORM US ON THE USED MATERIAL OF ABOVE-STATED BD EPIDURAL CATHETER. WE NEED THIS INFORMATION URGENTLY, AS THIS BD CATHETER WAS BROKEN OFF DURING INSERTION AND WE NEED THIS INFORMATION FOR DECIDING ON FURTHER IMAGING/DIAGNOSTICS AND CONSIDERATION OF THE NECESSITY OF A SURGICAL PROCEDURE FOR THE PATIENT. I EXPECT A RESPONSE TO OUR REQUEST AT A VERY SOON NOTICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19924354 ↗
• InjuryJul 18, 2024Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19771454 ↗
• MalfunctionNov 13, 2023Break; Break

  ANALYSIS IS CARRIED OUT UNDER INSTITUTIONAL METHODOLOGY. A PATIENT WITH 17 YEAR OLD, 42 KG, ADMITTED ON OCTOBER 9TH FOR MULTIPLE INTRA-ARTICULAR OSTEOTOMY PROCEDURE. IN THE PROCEDURE, THE EPIDURAL CATHETER IS PASSED WITHOUT COMPLICATIONS. AT THE TIME OF TRANSFER TO HOSPITAL, THE PATIENT LEAVES WITH THE EPIDURAL CATHETER PASSING BUPIVACAINE AT 9CC/H. WHEN THE PATIENT IS ADMITTED TO HOSPITAL, IT IS REPORTED THAT HER EPIDURAL CATHETER IS UNTIED, FOR WHICH PAIN CLINIC SUPPORT IS REQUESTED. AFTER ANESTHESIOLOGY INTERVENTION, THE CATHETER WAS CHECKED AND IT WAS RECORDED THAT THERE WAS NO EVIDENCE OF CATHETER LEAKAGE OR BLEEDING MARKS. IN ADDITION, MORPHINE RESCUE (2 MG) WAS PERFORMED, TO WHICH THERE WAS GOOD PAIN MODULATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITH GOOD PAIN MODULATION. FROM ANESTHESIOLOGY, THE ANALYSIS WAS CARRIED OUT STATING THAT ¿WITH THIS BRAND THERE WAS A DIFFICULTY BECAUSE THE KEY THAT FITS THE CATHETER IS SCREW TYPE TIGHTENING, WHICH REQUIRES DOING IT WITH FORCE, BUT EVEN SO IT LOOSENS WHICH CAUSES IT TO BREAK. UNTIE THE CATHETER KEY. THIS IS WHAT HAPPENED IN THIS PARTICULAR CASE¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121290 ↗
• MalfunctionOct 20, 2023Material Fragmentation; Defective Component; Material Fragmentation; Defective Component

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981503 ↗
• MalfunctionJan 19, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD PERISAFE¿ EPIDURAL MINI-KIT THERE WAS A CLOG. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OUT OF THREE SIDE PORT IS BLOCKED WHEN THEY CHECKED OUTSIDE BODY SO THEY NOT USED FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16203939 ↗
• MalfunctionJan 13, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED WHILE USING BD PERISAFE¿ EPIDURAL MINI-KIT THERE WAS A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: EPIDURAL PUMPS ON VERLOS ARE GOING INTO ALARM MORE FREQUENTLY (DUE TO OBSTRUCTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161183 ↗
• MalfunctionDec 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING (BRAND NAME) LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK DURING INJECTION PRESSURE WITH A 5ML SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929826 ↗
• MalfunctionDec 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PERISAFE¿ EPIDURAL MINI-KIT THERE WAS NO RESISTANCE IN THE SYRINGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: 1/NO RESISTANCE AT THE LEVEL OF THE SYRINGE PISTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926051 ↗
• MalfunctionDec 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD PERISAFE¿ EPIDURAL MINI-KIT THE PLUNGER HAD NO RESISTANCE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: 3/LOSS OF RESISTANCE OF THE SYRINGE RESISTANCE IS NOT PERCEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925980 ↗
• MalfunctionJan 11, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED 60 BD PERISAFE¿ EPIDURAL MINI-KITS HAD DEFORMED TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER REMOVING SUCH PROBLEMATIC CATHETERS, KINKED CATHETER TUBES ARE ALWAYS NOTICEABLE."

  Patient problems: Insufficient Information

  MAUDE report 13232545 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED WHEN USING THE BD KIT PERISAFE 18GA 3-1/2IN WEISS THE CATHETER BROKE APART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE ANESTHESIOLOGIST INSERTED PERISAFE IN THE PATIENT AND WHILE REMOVING THE EPIDURAL NEEDLE, THE TIP OF THE EPIDURAL CATHETER GOT CUT AROUND 1 CM. THE DR WAS SUSPECTING THE TIP OF THE EPIDURAL CATHETER REMAINS IN THE PATIENT WHILE REMOVING IT. HOWEVER POST OPERATION, THEY WILL PERFORM A XRAY AND CT SCAN." NO FURTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006333 ↗
• InjuryOct 29, 2021Break; Break

  IT WAS REPORTED THAT KIT PERISAFE 18GA 3-1/2IN WEISS CANNULA BROKE AND WAS THOUGHT TO HAVE THE MISSING PIECE INSIDE THE PATIENT. IT WAS DETERMINED THAT THE CANNULA WAS SHORTER AND DID NOT BREAK OFF INSIDE THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DR. WHO INFORMED ME THAT ONE OF THEIR ANESTHETISTS FOUND THE 20G EPIDURAL CATHETER CONTAINED IN OUR EPIDURAL KIT COD. CUT AND 4 CM SHORTER, FOLLOWING REMOVAL FROM THE PATIENT WHO WAS TO RECEIVE EPIDURAL ANESTHESIA. FROM THE X-RAY EXAMINATION, THE PATIENT DOES NOT SEEM TO HAVE THE MISSING PIECE INSIDE BUT WAS UNABLE TO RECEIVE THE REQUIRED ANESTHESIA / ANALGESIA. DR. TOGETHER WITH THE USER ANESTHETIST ASSUME THAT THE CATHETER WAS DEVOID OF THE 4 CMS PROXIMAL TO THE TIP BEFORE USE ON THE PATIENT. DR. IS COLLECTING ALL THE INFORMATION TO ISSUE THE ACCIDENT / COMPLAINT REPORT. IN THE NEXT FEW HOURS WE WILL HAVE MORE DETAILS ON THE INCIDENT. REASON FOR USE OF DEVICE: PERIDUAL ANALGESIA IN SPONTANEOUS DELIVERY. INCIDENT DESCRIPTION: THE CATHETER IS INSERTED INTO THE PERIDUAL SPACE FOUND AT 4.5 CM FROM THE SKIN WITH SLIGHT RESISTANCE, THEREFORE IN THE ATTEMPT TO RETRACT THE CATHETER, EVEN WITHOUT EXERTING ANY FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12723306 ↗
• MalfunctionOct 21, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT 2 BD PERISAFE¿ KITS EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FILTER IS MISSING IN BD PERISAFE KIT ( 2 UNITS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675867 ↗
• InjurySep 16, 2021Break; Break

  IT WAS REPORTED THAT THE KIT PERISAFE 18GA 3-1/2IN WEISS EXPERIENCED A CATHETER THAT BROKE APART. A BROKEN PORTION OF THE CATHETER MAY HAVE REMAINED WITHIN THE PATIENT, AND A CT SCAN WAS PERFORMED. NO BROKEN PIECE OF THE DEVICE WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EPIDURAL CATHETER TIP CUT AND MISSING DURING PROCEDURE. IN ONE OF THE PATIENTS BEFORE ORTHO SURGERY, PATIENT WAS ABOUT TO RECEIVE EPIDURAL ANESTHESIA, DOCTOR HAS INSERTED CATHETER IN PATIENT AND WHILE REMOVING THE EPIDURAL NEEDLE, THE TIP OF THE EPIDURAL CATHETER GETS CUT AND MISSED IT. THEY ARE SUSPECTING THAT THE TIP OF EPIDURAL CATHETER REMAINS IN THE PATIENT WHILE REMOVING IT. HOWEVER POST OPERATION, THEY HAVE DONE THE CT SCAN OF PATIENT TO CHECK WHETHER TIP REMAINS IN IT OR NOT. BUT AS PER DISCUSSION THEY HAVE NOT FIND ANYTHING IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484921 ↗
• InjurySep 15, 2021Break; Break

  IT WAS REPORTED THAT THE KIT PERISAFE 18GA 3-1/2IN WEISS EXPERIENCED THE CATHETER BREAKING APART. AN X-RAY WAS ADMINISTERED TO THE PATIENT IN AN ATTEMPT TO LOCATE A BROKEN PIECE OF THE DEVICE BELIEVED TO BE EMBEDDED WITHIN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER BROKEN WHILE REINSERTING IN THE PATIENT. THE DR AT THE HOSPITAL WAS USING PERISAFE ON THE PATIENT, THEY TRIED TO REINSERT IN 2ND ATTEMPT WHILE REINSERTING THEY NOTICED THAT 2-3 CM OF CATHETER WAS BROKEN AND TRIED TO LOCATE THE BROKEN PART. THEY TRIED TO LOCATE BY TAKING X-RAY, CT OF LUMBAR REGION AND ULTRASOUND BUT COULD NOT LOCATE THE SAME. HOWEVER THEY CONFIRMED THE PATIENT IS DOING FINE AS OF NOW. THEY COMPLETED THE PROCEDURE BY USING ANOTHER UNIT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12477868 ↗
• MalfunctionJun 2, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 10 KIT PERISAFE 18GA 3-1/2IN WEISS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLACK MARK ON THE CATHETER COMES OFF ON CONTACT WITH THE SKIN DISINFECTANT (DESDERMAN, STERILIUM AND KODAN FORTE WERE TESTED). WITHOUT THE MARKING, THE USER CAN NO LONGER SEE HOW FAR THE CATHETER MUST BE INSERTED OR WHETHER THE CATHETER HAS BEEN COMPLETELY REMOVED, AND IT CAN LEAD TO COMPLICATIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926426 ↗
• MalfunctionMay 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD PERISAFE¿ 18GA 3-1/2IN THERE WAS AN ISSUE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING ISSUE WITH THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829637 ↗
• MalfunctionFeb 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A KIT PERISAFE 18GA 3-1/2IN WEISS LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "INITIALLY, APPLICATION HAD NO COMPLICATIONS. IN THE COURSE OF THE OPERATION, A PUDDLE OF FLUID IN THE AREA OF THE FILTER OF THE EPIDURAL SET HAS BEEN NOTICED. CHECKED FOR ANY LEAKS BY PLACING A DRY CLOTH UNDERNEATH. NEW FORMATION OF FLUID HAS BEEN OBSERVED. INSPECTION REVEALS FLUID LEAKAGE IN THE AREA OF THE PROXIMAL LUER LOCK AT THE CONNECTION TO THE FILTER. WHEN THE PERIDURAL CATHETER TUBE IS ROTATED, THE LUERLOCK CONNECTION DISCONNECTS FROM THE FILTER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11269637 ↗
• InjuryNov 25, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT KIT PERISAFE 18GA 3-1/2IN WEISS GRADUATION MARKINGS WERE MISSING, AND THE FILTER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ERROR 1: THE BLACK MARK ON THE CATHETER COMES OFF WITH A SIMPLE WIPE DISINFECTION. WITHOUT THE MARKING, THE USER CAN NO LONGER SEE HOW FAR THE CATHETER HAS TO BE INSERTED AND COMPLICATIONS CAN ARISE. ERROR 2: THE FILTER CONTAINED IN THE SET BREAKS WHEN CONNECTING. THIS ERROR SOMETIMES OCCURS WHEN CONNECTING FOR THE FIRST TIME. SOMETIMES THE MATERIAL TEARS, SOMETIMES IT SPLINTERS. IN ONE SPECIFIC CASE, THE ADMINISTRATION OF PAIN MEDICATION DURING LUNG SURGERY IN A NINE-YEAR-OLD FEMALE PATIENT WAS NOT SUCCESSFUL BECAUSE THE MEDICATION RAN UNNOTICED NEXT TO THE PATIENT DUE TO THE DAMAGED FILTER. THIS LED TO CONSIDERABLE COMPLICATIONS. PATIENT SAFETY IS CONSIDERABLY ENDANGERED BY THIS ERROR.

  Patient problems: Underdose

  MAUDE report 10901846 ↗
• MalfunctionNov 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PERISAFE¿ EPIDURAL MINI-KIT FILTER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "WHEN PUNCTURING AND AFTER CONNECTING THE FILTER, IT APPEARS THAT THE FILTER IS LEAKING. NOT THERE HEIGHT OF THE CONNECTORS, BUT THERE IS IN THE MIDDLE OF THE SIDE, DROPLET FORMATION IS SEEN (EXACTLY AS IF THERE IS A HOLE IN THE SIDE OF THE DISC OR IT LEAKS AT THE SIDE OF THE DISC)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848321 ↗
• InjuryOct 10, 2020Break; Break

  IT WAS REPORTED THAT THE KIT PERISAFE 18GA 3-1/2IN WEISS EXPERIENCED THE CATHETER BREAKING APART AFTER USE. PATIENT REQUIRED MEDICAL INTERVENTION IN THE FORM OF A BODY SCAN AND REMOVAL OF THE EMBEDDED PIECE OF THE DEVICE. NO ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE PERISAFE CATHETER, IT IS VISUALIZED THAT IT DOES NOT COME OUT COMPLETELY. PATIENT IS SCANNED, BUT NO CATHETER FRAGMENT IS SEEN. ADD. INFORMATION: I INFORM YOU THAT THE PATIENT HAD TO TAKE A LUMBAR SPINE SCANNER WITHOUT CONTRAST AND A CONSULTATION WITH A NEUROSURGEON. INFORMATION RECEIVED SEPTEMBER 24, 2020: THE CATHETER FRAGMENT WAS NOT SEEN IN THE LUMBAR SPINE SCAN. NEUROSURGEON SPOKE WITH PATIENT. I KNOW THAT PATIENT IS FINE AT THE MOMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10659910 ↗