BD Perisafe, BD Epilor, BD Luer-Lok 405828Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 50382904058284), received between Jan 7, 2019 and Jul 19, 2024 — classified as 3 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (14 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 36 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 20, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE EPIDURAL CATHETER IN THE BD® COMBINED SPINAL EPIDURAL TRAY WAS BLOCKED/OCCLUDED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD SEVERAL EPIDURAL CATHETERS THAT SEEM TO BE OCCLUDED, OR NOT ALLOWING SMOOTH INJECTION." "WE HAD A CASE LAST WEEK, THOUGHT THE CATHETER HAD CLOTTED SO WE REPLACED IT (IT WAS A CATHETER YOU HAD ACTUALLY PLACED). WHEN WE REPLACED, I ¿PLAYED¿ WITH THE OLD ONE, AND FOUND THAT 1 HOLE WAS OBSTRUCTED BUT THEN WAS ABLE TO FLUSH"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497858 ↗
• MalfunctionJun 4, 2021Break; Break

  IT WAS REPORTED THAT TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE USER FACILITY THAT THERE ARE REPORTS OF THE CATHETER BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941348 ↗
• MalfunctionMay 6, 2021Break

  BD COMBINED EPIDURAL SPINAL KIT 405828, LOT 0001393406 HAS HAD REPEATED EPIDURAL CATHETER FAILURES. CATHETER BREAKS EXCESSIVELY EASILY. NONE HAVE BROKEN WITHIN A PATIENT. ALL HAVE BROKEN PRIOR TO THE TAPE BEING REMOVED AND THE CATHETER BEING REMOVED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790115 ↗
• MalfunctionMar 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. THERE HAS BEEN SOME MORE ISSUES WITH THE EPIDURAL CATHETER INSIDE THIS CSE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408073 ↗
• MalfunctionDec 23, 2020Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 CATHETER WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405828; BATCH NO: UNKNOWN (PROVIDED 0003177963). IT WAS REPORTED THAT THE EPIDURAL CATHETER IN THE KIT DOES NOT SEEM TO BE PATENT; UNABLE TO PUSH MEDS THROUGH IT. EVENT DESCRIPTION PER EMAIL STATES: EPIDURAL CATHETER IN KIT DOES NOT SEEM TO BE PATENT AND I CANNOT PUSH MEDS THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11067421 ↗
• MalfunctionMar 24, 2020Break; Break

  IT WAS REPORTED THAT THE FLAT FILTERS ARE BREAKING DURING USE WITH A BD COMBINED SPINAL EPIDURAL TRAY 17G X 3.5". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT FLAT FILTERS ARE BREAKING ON POST-OP PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9872494 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED THAT BREAKAGE OCCURRED AT AN UNSPECIFIED TIME WITH A TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "EPIDURAL CATHETER BROKE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112489 ↗
• MalfunctionJul 26, 2019Break; Break

  IT WAS REPORTED THAT THE TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 EXPERIENCED A CATHETER THAT BROKE APART DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405828, BATCH NO. UNKNOWN. PER EMAIL: NO LOT NUMBERS AND ALL ISSUES WITH TRAY 405828: CATHETER DISCONNECTED FROM CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8833585 ↗
• MalfunctionJul 16, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 405828 BATCH NO. UNKNOWN IT WAS REPORTED THAT DURING USE OF THE TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 THE HOSPITAL HAD ONE TRAY MISSING TAGADERM, ONE TRAY MISSING FLAT FILTER, AND ONE TRAY WITH A BROKEN GLASS SYRINGE. TWO KITS HAD LEAKING FILTERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HOSPITAL ONE TRAY WAS MISSING A TEGADERM, ANOTHER TRAY MISSING A FLAT FILTER, ANOTHER TRAY WITH BROKEN GLASS SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8794404 ↗
• MalfunctionJun 27, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A TRAY HAD A BROKEN GLASS SYRINGE, ONE TRAY HAD THE NEEDLE COMING OUT OF THE WRAPPING AND ANOTHER TRAY HAD SPINAL NEEDLE COMING OUT OF PROTECTIVE SLEEVE AND INTRODUCER WAS BENT WITH A BD TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795. THESE WERE DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IN 3 TRAYS ONE HAD A BROKEN GLASS SYRINGE, ONE TRAY HAD THE NEEDLE COMING OUTSIDE OF THE WRAPPING, AND THE THIRD TRAY HAD A SPINAL NEEDLE COMING OUT OF PROTECTIVE SLEEVE AND INTRODUCER WAS BENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739492 ↗
• MalfunctionJun 19, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 BLUNT FILL NEEDLE WAS FOUND ON TOP OF THE WRAPPING BEFORE USE, PRESENTING A STERILITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCONSISTENT BLUNT FILL NEEDLE ON TOP OF WRAPPING''. STATED THAT THE NEEDLE WAS ON TOP OF THE WRAPPING BUT SHOULD BE UNDER / WRAPPED IN THE WRAPPING. THE SALES REP NOTED THAT THIS DOES CAUSE A STERILITY ISSUE WHEN OPENING THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8711895 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT THE TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795 CATHETER DISCONNECTED FROM THE CONNECTOR AFTER THE PLACEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CATHETER DISCONNECTED FROM THE CONNECTOR AFTER PLACEMENT. PLACED SECOND CATHETER WITH NO AES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8703858 ↗