BD Perisafe, BD Epilor, BD Luer-LokRecalls & reported problems across all models
Becton, Dickinson And Company · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 9 models of BD Perisafe, BD Epilor, BD Luer-Lok by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2018 and May 21, 2025 — classified as 4 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Break” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Perisafe, BD Epilor, BD Luer-Lok problems
Device problems
- Break21
- Leak/Splash20
- Device Markings/Labelling Problem6
- Packaging Problem5
- Complete Blockage3
- Device Contamination with Chemical or Other Material3
- Disconnection3
- Crack2
Patient problems
- No Known Impact Or Consequence To Patient38
- No Clinical Signs, Symptoms or Conditions21
- No Patient Involvement3
- Device Embedded In Tissue or Plaque2
- No Consequences Or Impact To Patient2
- Exposure to Body Fluids1
- Extravasation1
- Needle Stick/Puncture1
BD Perisafe, BD Epilor, BD Luer-Lok models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Perisafe, BD Epilor, BD Luer-Lok 405828Anesthesia conduction kit36 reports
- BD Perisafe, BD Epilor, BD Luer-Lok 406047Anesthesia conduction kit15 reports
- BD Perisafe, BD Epilor, BD Luer-Lok 406151Anesthesia conduction kit10 reports
- BD Perisafe, BD Epilor, BD Luer-Lok 405823Anesthesia conduction kit2 reports
- BD Perisafe, BD Epilor, BD Luer-Lok 406069Anesthesia conduction kit2 reports
- BD Perisafe, BD Epilor, BD Luer-Lok 406048Anesthesia conduction kit1 report
- BD Perisafe, BD Epilor, BD Luer-Lok 406049Anesthesia conduction kit1 report
- BD Perisafe, BD Epilor, BD Luer-Lok 406060Anesthesia conduction kit1 report
- BD Perisafe, BD Epilor, BD Luer-Lok 406091Anesthesia conduction kit1 report
Recent BD Perisafe, BD Epilor, BD Luer-Lok adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
MATERIAL # 406069, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT HOLES OR TEARS IN DRAPE WHEN OPENING THE STERILE TRAY VERBATIM: HOLES OR TEARS IN DRAPE WHEN OPENING THE STERILE TRAY. THIS HAS OCCURRED WITH A FEW DIFFERENT TRAYS. THE DRAPES WERE USED, BUT NO PT INJURY OR ADVERSE EVENT. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? 05-08-2025. 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? UNFORTUNATELY, WE ARE NOT CERTAIN THIS MAY HAVE BEEN THE SAME LOT # AS THE TRAYS WITH DRAPE HOLES/TEARS. WE RECEIVE SEVERAL CASES EVERY OTHER DAY. LOT #0001611311.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22059928 ↗MalfunctionJul 19, 2024Leak/Splash; Leak/Splash
THE FOLLOWING WAS REPORTED VIA EMAIL: CLAUDIA HAD TO REPAIR A CATHETER THIS EVENING THAT HAD DISCONNECTED. AS SHE WAS RELAYING THE STORY, DR. MANCZUR STATED THAT ONE TODAY SEEMED TO BE VERY SLIGHTLY LEAKING AT THE CATHETER/CONNECTOR INTERFACE WHEN THEY WERE GIVING A LOADING DOSE OR THE TEST DOSE. ADDITIONAL RESPONSES REPORT: THIS ONE WAS THE KIT THAT CAUSED INTRAVASCULAR CATHETERIZATION LAST NIGHT (DIFFERENT LOT FROM THE ONE WITH CONNECTOR ISSUES). 26JUN2024 COMMUNICATION STATES: SOME OF THE YELLOW CONNECTORS DON¿T ALLOW THE CATHETER TO GO ALL THE WAY IN AND THEREFORE DON¿T WORK RIGHT ( HAD ONE THIS MORNING) WE DID HAVE 4 OR 5 OF THE EXTRA CONNECTORS ( WHICH ARE HALF YELLOW AND HALF CLEAR PLASTIC) IN OUR CART **PLEASE SEE EMAIL CHAIN FROM CUSTOMER ATTACHED. MULTIPLE ISSUES WERE NOTED WITHIN THE SAME COMMUNICATION. BD WAS NOTIFIED OF THESE ISSUES ON 26JUN 2024. RESPONSE RECEIVED 27JUN2024 PER DR. RICHARD SMILEY: 2. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? IF INVOLVED, DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. YES, THIS DID OF COURSE INVOLVE A PATIENT, ALTHOUGH NO SIGNIFICANT HARM WAS DONE. TWIC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19781972 ↗MalfunctionJul 19, 2024Disconnection; Disconnection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19781849 ↗MalfunctionJul 18, 2024Leak/Splash; Leak/Splash
MATERIAL # 405828, BATCH # 0001563972, 0001527093, 0001561237. IT WAS REPORTED BY CUSTOMER THAT LOT NO. 0001563972 ALSO DEFECTIVE EITHER THE CATHETER OR THE ADAPTER IS WRONG SIZE. VERBATIM: LOT NO. 0001563972 ALSO DEFECTIVE EITHER THE CATHETER OR THE ADAPTER IS WRONG SIZE. OUR ANESTHESIA 4TH FLOOR SUPPLY ROOM, ALL ARE THESE LOT NUMBERS. PULLING THEM OUT AND SET ASIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19770701 ↗MalfunctionJul 15, 2024Leak/Splash; Leak/Splash
MATERIAL #: 405828 BATCH#: 0001563972. IT WAS REPORTED BY CUSTOMER STATES THAT THEY ARE HAVING ISSUES WITH 2 EPIDURAL TRAYS. IN ONE TRAY, THE CLAMPS ARE LEAKING AND IN THE OTHER TRAY, THE PAPER COVERING IS NOT GLUED DOWN. THE CUSTOMER HAS THE TRAY WHERE THE PAPER IS NOT GLUED DOWN IF NEEDED FOR INVESTIGATION. REF NUMBER: 405828; LOT NUMBER: 0001563972. CARDINAL HEALTH IS THEIR DISTRIBUTOR. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. CUSTOMER STATES THAT THEY ARE HAVING ISSUES WITH 2 EPIDURAL TRAYS. IN ONE TRAY, THE CLAMPS ARE LEAKING AND IN THE OTHER TRAY, THE PAPER COVERING IS NOT GLUED DOWN. THE CUSTOMER HAS THE TRAY WHERE THE PAPER IS NOT GLUED DOWN IF NEEDED FOR INVESTIGATION. REF NUMBER: 405828; LOT NUMBER: 0001563972. CARDINAL HEALTH IS THEIR DISTRIBUTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740694 ↗MalfunctionJul 15, 2024Packaging Problem; Packaging Problem
MATERIAL #: 405828 BATCH#: 0001563972 IT WAS REPORTED BY CUSTOMER STATES THAT THEY ARE HAVING ISSUES WITH 2 EPIDURAL TRAYS. IN ONE TRAY, THE CLAMPS ARE LEAKING AND IN THE OTHER TRAY, THE PAPER COVERING IS NOT GLUED DOWN. THE CUSTOMER HAS THE TRAY WHERE THE PAPER IS NOT GLUED DOWN IF NEEDED FOR INVESTIGATION. REF NUMBER: 405828; LOT NUMBER: 0001563972. (B)(4) IS THEIR DISTRIBUTOR. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED CUSTOMER STATES THAT THEY ARE HAVING ISSUES WITH 2 EPIDURAL TRAYS. IN ONE TRAY, THE CLAMPS ARE LEAKING AND IN THE OTHER TRAY, THE PAPER COVERING IS NOT GLUED DOWN. THE CUSTOMER HAS THE TRAY WHERE THE PAPER IS NOT GLUED DOWN IF NEEDED FOR INVESTIGATION. REF NUMBER: 405828; LOT NUMBER: 0001563972. (B)(4) IS THEIR DISTRIBUTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740658 ↗InjuryMay 20, 2024Break; Break
NO ADDITIONAL INFORMATION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19350651 ↗MalfunctionMay 16, 2024Packaging Problem; Packaging Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19333254 ↗MalfunctionSep 2, 2023Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY WAS CRACKED CAUSING LEAKAGE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WE ARE HAVING MAJOR ISSUES WITH THE CONNECTORS FOR THE CATHETER IN OUR CURRENT CSE KIT. THEY CRACK AND EPIDURAL SOLUTION IS DELIVERED TO THE BED INSTEAD OF THE EPIDURAL SPACE. ADDITIONAL INFO RECEIVED ON 21-JULY-23 WAS THIS NOTED PRIOR TO USE? NO IT WAS NOT NOTED PRIOR TO USE. ALL CONNECTORS WERE USED AND CRACKED AFTER INITIAL DOSING/ADMINISTRATION OF TEST DOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17674814 ↗MalfunctionAug 3, 2023Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY WAS CRACKED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING MAJOR ISSUES WITH THE CONNECTORS FOR THE CATHETER IN OUR CURRENT CSE KIT. THEY CRACK AND EPIDURAL SOLUTION IS DELIVERED TO THE BED INSTEAD OF THE EPIDURAL SPACE. PLEASE ADVISE ON NEXT STEPS TO CORRECT THE ISSUE AS THIS IS A PATIENT SAFETY CONCERN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17456196 ↗MalfunctionMar 29, 2023Defective Component; Defective Component
IT WAS REPORTED THAT 15 OF THE BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY LOCK WAS INEFFECTIVE, CAUSING THE CATHETER TO BE DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEXUS CATHETER LOCK WAS FOUND TO BE INEFFECTIVE, CAUSING THE CATHETER TO BE DISCONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16638515 ↗MalfunctionFeb 26, 2023Break; Break
IT WAS REPORTED WHILE USING BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY THE CATHETER ADAPTOR DISLODGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEXUS CATHETER ADAPTER CAME DISLODGED FROM CATHETER RESULTING IN DELAY IN MEDICATION ADMINSTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16441163 ↗MalfunctionFeb 4, 2023Disconnection; Disconnection
IT WAS REPORTED THAT THE BD® COMBINED SPINAL EPIDURAL TRAY CATHETER AND NEXUS CATHETER DISCONNECTED DURING USE. THIS OCCURRED WITH 3 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEXUS CATHETER DISCONNECTED FROM THE EPIDURAL CATHETER DESPITE THE CLINICIAN SECURING DURING PLACEMENT. THIS IS THE THIRD INCIDENT IN THE PAST WEEK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16301603 ↗MalfunctionJan 26, 2023Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD® WHITACRE SPINAL NEEDLE 27 G X 4 11/16 IN. THE ADAPTOR WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CATHETER TO BE DISCONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16248947 ↗MalfunctionJan 25, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE EPIDURAL CATHETER IN THE BD® COMBINED SPINAL EPIDURAL TRAY WAS CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT REQUIRED SPINAL ANESTHESIA SINCE THE EPIDURAL CATHETER WAS CONTAMINATED FOR AN UNKNOWN AMOUNT OF TIME."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16239447 ↗
Other Becton, Dickinson And Company products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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