BD Perisafe, BD Epilor, BD Luer-Lok 406151Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 50382904061512), received between May 1, 2019 and Apr 27, 2020 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRAY EPID CONT WE17G3.5 SWC X3796 EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 406151, BATCH NO: UNKNOWN. I DON'T HAVE A LOT NUMBER ¿ THEY KEPT THE TOP COVER BUT THE LOT NUMBER IS NOT ON THAT. THEY SAID THE EPIDURAL WAS LEAKING AT THE HTE CONNECTION OF THE TUBE AN CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10002594 ↗
• MalfunctionDec 20, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND IN THE TRAY EPID CONT WE17G3.5 SWC X3796. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY FOUND A HAIR IN ONE OF THE ANESTHESIA TRAYS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9504898 ↗
• MalfunctionOct 23, 2019Break; Break

  IT WAS REPORTED THAT THE STING RAY DISCONNECTED FROM THE EPIDURAL CATHETER DURING USE WITH A BD TRAY EPID CONT WE17G3.5 SWC X3796. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE BLUE STING RAY DISCONNECTED FROM THE EPIDURAL CATHETER. THE EPIDURAL WORKED FINE DURING LABOR. I THINK THE BLUE STING RAY GOT DISCONNECTED AFTER DELIVERY BUT IM NOT SURE HOW/WHEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9225815 ↗
• MalfunctionSep 23, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SEPARATION OCCURRED WITH A TRAY EPID CONT WE17G3.5 SWC X3796. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "OF COURSE, MY PATIENT WAS COMPLETE AND LABORING DOWN WE WERE USING THE PEANUT BALL AND MOVING SIDE TO SIDE. AFTER DOING THAT SHE CALLED OUT SAYING SHE WAS STARTING TO FEEL SOME PRESSURE WE STARTED PUSHING DURING THAT TIME IS WHEN IT MUST BROKE, BECAUSE HALF WAY THROUGH SHE WAS IN EXTREME PAIN. WE CALLED ROY THE CRNA AND HE CAME TO EVALUATE THE PATIENT AND SAW IT DISCONNECTED AND NOT WORKING AT THIS TIME HE REPLACED THE CLE AND THE PATIENT WAS ABLE TO DELIVER AND PUSH AND DELIVER."

  Patient problems: Pain

  MAUDE report 9106484 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A TRAY EPID CONT WE17G3.5 SWC X3796. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "OB REPORTS STINGRAY CONNECTORS ARE DISCONNECTING FROM EPIDURAL CATHETERS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8854897 ↗
• MalfunctionJul 9, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CONNECTOR DISCONNECTION OCCURRED DURING USE WITH A TRAY EPID CONT WE17G3.5 SWC X3796. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT STINGRAY CONNECTOR IS DISCONNECTING FROM CATHETER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8773878 ↗
• MalfunctionJul 1, 2019Break; Break

  IT WAS REPORTED THAT BD¿ TRAY EPID CONT WE17G3.5 SWC X3796 CATHETER WAS DISCONNECTED. THIS OCCURRED ON 5 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 406151, BATCH NO. UNKNOWN. IT WAS REPORTED THAT STINGRAY DISCONNECTING FROM EPIDURAL CATHETER. PER PIR: (B)(6) REPORTS THAT THEY HAVE HAD 5 EPIDURAL CATHETER CONNECTORS DISCONNECT FROM THE STINGRAY CONNECTOR, IN THE LAST 2 WEEKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8750753 ↗
• MalfunctionJun 24, 2019Leak/Splash; Device Markings/Labelling Problem; Leak/Splash; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CATHETER FROM THE TRAY EPID CONT WE17G3.5 SWC X3796 DISCONNECTED FROM THE STINGRAY DURING AN EPIDURAL ON AN ICU PATIENT, AND THE NURSES STATED THE CATHETER WAS NOT ONE THEY HAD SEEN BEFORE. ADDITIONALLY, IT WAS REPORTED THAT THE ANESTHESIOLOGIST HAD TO BE CALLED IN THE MIDDLE OF THE NIGHT TO WALK THE STAFF THROUGH THE SITUATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OTHER NIGHT, THE ICU HAD A PATIENT WITH AN EPIDURAL CATHETER THAT BECAME DISCONNECTED. THE NURSES REPORTED THIS WAS NOT AN EPIDURAL CATHETER THEY HAD EVER SEEN BEFORE. THEY CALLED ANESTHESIA IN THE MIDDLE OF THE NIGHT AND THE ANESTHESIOLOGIST TALKED THEM THROUGH WHAT TO DO FOR A DISCONNECT OF THIS TYPE OF CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8728223 ↗
• MalfunctionJun 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT CATHETER DISCONNECTING FROM ADAPTER WITH A BD TRAY EPID CONT WE17G3.5 SWC X3796. THIS OCCURRED ON 10 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 406151, BATCH NO: UNKNOWN. IT WAS REPORTED THAT EPIDURAL CATHETERS ARE DISCONNECTING FROM STINGRAY WHILE IN USE. PER CUSTOMER: THE PROBLEM IS THAT EVEN WHEN IT¿S SEATED CORRECTLY, WITH ENOUGH TRACTION IT POPS OUT. UNFORTUNATELY THERE¿S A LOT OF MOVEMENT WITH LABORING WOMEN EVEN WITH AN EPIDURAL. WE ARE TURNING THEM SIDE TO SIDE. IN AN EMERGENCY, IT IS A QUICK FLIP. DURING PUSHING, THE POSITIONING OF THE PATIENT PUTS MORE TRACTION ON IT AS WELL. ANESTHESIOLOGISTS ARE TAPING THE STINGRAY CLOSED AND ATTACHING TO PATIENT TO PREVENT DISCONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8705688 ↗
• MalfunctionMay 1, 2019Misassembled

  IT WAS REPORTED THAT THERE WERE 10 OCCURRENCES WITH CATHETER GUIDE WIRE BEING ASSEMBLE INCORRECTLY WITH A BD TRAY EPID CONT¿ WE17G3.5 SWC X3796. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER GUIDE WIRE IS BEING ASSEMBLED BACKWARDS. PER DR.: THE NEW EPIDURAL KITS I WILL SAY THE CATHETER IS NOT BEING ASSEMBLED CORRECTLY. THE GUIDE THAT HELPS THE CATHETER GO THROUGH THE NEEDLE IS ON BACKWARDS AND WE HAVE TO TAKE IT OFF AND THEN SLIDE IT BACK ON, HANDLING THE CATHETER MULTIPLE TIMES. NOT GOOD FOR INFECTION CONTROL OR WHEN YOU NEED TO GET IT IN QUICKLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8571076 ↗