BD Perisafe, BD Epilor, BD Luer-Lok 406047Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 50382904060478), received between Jan 2, 2019 and Aug 10, 2021 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E EXPERIENCED NEEDLE HUB HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS WEEK WE HAD TWO CONNECTORS IN YOUR EPIDURAL KIT THAT HAD A HOLE IN THE SIDE. OK BOTH INSTANCES WE WERE ABLE TO BREAK OPEN ANOTHER TYPE OF KIT AND USE THEIRS, BUT I WANTED TO LET YOU KNOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303506 ↗
• InjuryOct 24, 2019Break; Break

  MATERIAL NO.: 406047. BATCH NO.: 0001310661. IT WAS REPORTED THAT DURING USE OF THE EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH THE NEEDLE FROM THE CATHETER BROKE OFF INSIDE THE PATIENT AND COULD NOT BE RETRIEVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER INCIDENT WITH ONE OF THE EPIDURAL TRAYS.. THIS TIME THE CATHETER NEEDLE BROKE OFF INSIDE THE PATIENT AND THEY WERE NOT ABLE TO RETRIEVE IT. THIS CAME FROM WITH LOT # 0001310661 AND REF 406047.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9233684 ↗
• MalfunctionSep 25, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT EPIDURAL TRAY PERISAFE¿ CONTINUOUS TUOHY 18 GAUGE 3-1/2 INCH HAD THE WRONG CATHETER INSIDE THE TRAY. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 406047, BATCH NO: UNKNOWN IT WAS REPORTED THAT THE WRONG CATHETER WAS INSIDE THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9117411 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT A THREADING ISSUE OCCURRED WITH A TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I HAVE TRIED TO USE TWO TRAYS TONIGHT AND THE FIRST ONE WAS FINE, THE SECOND ONE I CANNOT FEED THE CATHETER. I TRIED BOTH BEFORE PLACING A NEEDLE IN THE PATIENT. UNFORTUNATELY I DID NOT CHECK THE LOT NUMBER ON THE FIRST ONE BUT THE SECOND ONE IS THE SAME LOT NUMBER AS THE OTHER DEFECTIVE TRAYS." 2 OCCURRENCES WERE REPORTED. 1 OF 3 COMPLAINTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9072038 ↗
• MalfunctionSep 10, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 2 TRAYS EPID CONT WE18G3.5 C20 LOR5 S/L/L-E WERE FOUND BEFORE USE WITH 19G EPIDURAL CATHETERS, RATHER THAN THE 20G CATHETERS INDICATED ON THE LABELING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR ANESTHESIA GROUP IS COMING ACROSS A COMPONENT DISCREPANCY. BD CONTINUOUS EPIDURAL TRAY 406047 IS LABELED AS HAVING A 20G X36 IN EPIDURAL CATHETER. WE HAVE TWO TRAYS THAT CAME WITH 19G."

  Patient problems: No Patient Involvement

  MAUDE report 8981156 ↗
• MalfunctionSep 5, 2019Break; Break

  IT HAS BEEN REPORTED THAT THE TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E HAS BEEN FOUND EXPERIENCING INABILITY FOR THE CATHETER TO THREAD THROUGH THE NEEDLE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER IS NOT ABLE TO PASS CATHETER THROUGH NEEDLE. PER CUSTOMER EMAIL: MOST OF MY COMPLAINTS WERE MINOR IN NATURE AND HAVE BEEN ONGOING FOR A NUMBER OF MONTHS NOW BUT IN THE RECENT PAST I HAVE NOTICED INCREASING RESISTANCE TO PASSAGE OF THE CATHETER THRU THE NEEDLE. IT IS NOW TO A POINT WHERE I CANNOT PASS IT AT ALL. I CHECK EACH TIME BEFORE I PLACE A NEEDLE INTO A PATIENT NOW AND HAVE HAD SEVERAL KITS WHERE YOU CANNOT PASS THE CATHETER, ONE OF WHICH YOU CANNOT EVEN GET ONE CENTIMETER PAST THE HUB. OF NOTE, I HAVE USED THIS TRAY AT THE HOSPITAL WITHOUT INCIDENT HOWEVER I DO NOT KNOW THE LOT NUMBER OF THAT PARTICULAR TRAY. I HAVE USED THIS TRAY FOR WELL OVER 20 YEARS WITH ONLY MINOR COMPLAINTS IN THE PAST BUT THIS IS A VERY DIFFERENT SITUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8966866 ↗
• MalfunctionSep 5, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER CANNOT THREAD THROUGH THE NEEDLE WITH A BD TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: IT WAS REPORTED THAT CUSTOMER IS NOT ABLE TO PASS CATHETER THROUGH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MOST OF MY COMPLAINTS WERE MINOR IN NATURE AND HAVE BEEN ONGOING FOR A NUMBER OF MONTHS NOW BUT IN THE RECENT PAST I HAVE NOTICED INCREASING RESISTANCE TO PASSAGE OF THE CATHETER THRU THE NEEDLE. IT IS NOW TO A POINT WHERE I CANNOT PASS IT AT ALL. I CHECK EACH TIME BEFORE I PLACE A NEEDLE INTO A PATIENT NOW AND HAVE HAD SEVERAL KITS WHERE YOU CANNOT PASS THE CATHETER, ONE OF WHICH YOU CANNOT EVEN GET ONE CENTIMETER PAST THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8965405 ↗
• MalfunctionAug 26, 2019Break; Packaging Problem; Break; Packaging Problem

  IT HAS BEEN REPORTED THAT THE TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E HAS BEEN FOUND EXPERIENCING INABILITY FOR THE CATHETER TO THREAD THE NEEDLE AND PACKAGING ISSUES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:406047 BATCH NO: UNKNOWN. IT WAS REPORTED THAT CATHETER WAS MISSING, SYRINGES WERE STICKING OR THE OVERALL PACKING MADE IT DIFFICULT TO OPEN THE TRAY IN A STERILE FASHION. ALSO AT TIMES THE CATHETER WAS PLACED SUCH THAT WHEN YOU PICKED UP THE STERILE DRAPES, THE CATHETER WOULD DROP TO THE FLOOR. IT WAS ALSO REPORTED THAT THE CATHETER IS DIFFICULT TO PASS THROUGH THE NEEDLE. PER CUSTOMER EMAIL: I SPOKE TO YOU A FEW MONTHS AGO ABOUT THE PACKAGING OF THE EPIDURAL TRAYS. MY CONCERNS WERE THAT SOMETIMES THE CATHETER WAS MISSING, SYRINGES WERE STICKING OR THE OVERALL PACKING MADE IT DIFFICULT TO OPEN THE TRAY IN A STERILE FASHION. ALSO AT TIMES THE CATHETER WAS PLACED SUCH THAT WHEN YOU PICKED UP THE STERILE DRAPES, THE CATHETER WOULD DROP TO THE FLOOR. IN THE PAST FEW MONTHS I HAVE CONTINUED TO HAVE SOME OF THE SAME PROBLEMS LISTED ABOVE BUT NOW HAVE A MUCH MORE SERIOUS SAFETY ISSUE. THE CATHETER IS DIFFICULT TO PASS THRU THE NEEDLE LEADING M

  Patient problems: No Code Available

  MAUDE report 8931501 ↗
• MalfunctionAug 15, 2019Break; Break

  MATERIAL NO.: 406047. BATCH NO.: 0001285103. IT WAS REPORTED THAT DURING USE OF THE TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E THE DOCTOR HAD DIFFICULTY GETTING THE CATHETER THROUGH THE NEEDLE. IT WAS STATED THAT THE PACKAGE SAYS IT IS A 20 GAUGE CATHETER BUT IT IS ACTUALLY A 19 GAUGE CATHETER AND IT DOES NOT FIT THROUGH THE 18 GAUGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOW HAVE A LOT # AS IT HAS HAPPENED A COUPLE OF MORE TIMES. LOT #0001285103. THREE TIMES YESTERDAY AND ONCE THIS MORNING. I AM PULLING ALL TRAYS OF THIS LOT # FROM SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8896890 ↗
• MalfunctionAug 14, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INCORRECT NEEDLE LENGTH WAS IN THE TRAY WITH A BD TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E. THIS OCCURRED ON 2 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TWO TRAYS CONTAINED THE INCORRECT NEEDLE LENGTH. HEALTH CARE PROFESSIONAL CALLED TO REPORT THAT DOCTOR FOUND 2 KITS THAT HAD 19 G INSTEAD OF 20G LOT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8895032 ↗
• MalfunctionAug 12, 2019Break; Break

  IT WAS REPORTED THAT THREE TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E EXPERIENCED A CATHETER THAT COULD NOT THREAD THROUGH THE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 406047 BATCH NO.: 0001285103 VERBATIM: I NOW HAVE A LOT # AS IT HAS HAPPENED A COUPLE OF MORE TIMES. THREE TIMES YESTERDAY. I AM PULLING ALL TRAYS OF THIS LOT # FROM SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883130 ↗
• MalfunctionAug 7, 2019Break; Break

  IT WAS REPORTED THAT THE TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E CATHETER WOULD NOT THREAD THROUGH THE 18-GAUGE NEEDLE DURING USE ON A PATIENT. ADDITIONALLY, IT WAS REPORTED THAT THE PACKAGING STATED THE DEVICE WAS A "20 GAUGE" CATHETER, BUT THE CUSTOMER ALLEGED IT WAS "ACTUALLY A 19 GAUGE CATHETER". THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THAT THE PACKAGE SAY 20 GUAGE CATHETER, BUT IS ACTUALLY A 19 GAUGE CATHETER, AND IT DOES NOT FIT THROUGH THE 18 GAUGE NEEDLE. CUSTOMER STATES THAT THE DOCTOR HAD AN ISSUE THIS MORNING. PRODUCT WAS USED ON PATIENT, BUT DOCTOR HAD DIFFICULTY GETTING THE CATHETER THROUGH THE NEEDLE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8869710 ↗
• MalfunctionJul 29, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 406047 BATCH NO: 0001285103. VOICEMAIL RECEIVED WHICH MENTIONED AN ISSUE WITH ITEM 406047. THE VOICEMAIL CUT IN AN OUT BUT IT SEEMS THAT ONE OF THE COMPONENTS IN THE TRAY IS NOT CORRECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8838906 ↗
• MalfunctionFeb 19, 2019Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E HAD DISCONNECTED "BETWEEN THE EPIDURAL CATHETER AND THE YELLOW TUBING", WITH THE TUBING "LEAKING ROP/FENT ON THE FLOOR", WHILE 30 MINUTES LATER, LEAKAGE WAS ALSO DISCOVERED AT THE "CONNECTION PIECE", WHICH WAS NOTICED TO BE CRACKED UPON REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351467 ↗
• MalfunctionJan 2, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E CONNECTOR BETWEEN THE CATHETER AND EPIDURAL SYRINGE PULLED APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210135 ↗