BD Luer-Lok, BD Glaspak 405673Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 50382904056730), received between Jun 25, 2019 and Jul 21, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 27, 2026Class IOpen, Classified

   This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.

   Z-2255-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION: INEFFECTIVE ANESTHESIA, EPIDURAL PLACED. EVENT DETAILS: WE EXPERIENCED A TOTAL OF 5 FAILED SPINALS (4 WITHIN THE PAST WEEK, THE OTHER 1 EARLIER IN THE MONTH) AND ARE QUESTIONING THE EFFICACY OF THE INCLUDED MEDICATIONS AS THAT IS THE PRIMARY CONSISTENT FACTOR DURING THESE EVENTS THAT OCCURRED. WE ARE STILL CONFIRMING THE NUMBER OF REPORTS AND VERIFYING NONE OF THESE HAVE BEEN DUPLICATED, BUT THIS IS THE DETAIL WE HAVE RECEIVED SO FAR. NO SPECIFIC PATIENT HARM WAS REPORTED, ALTHOUGH CONVERSION TO GENERAL ANESTHESIA WAS REQUIRED SO THE ASSOCIATED ADDITIONAL RISKS THAT GO ALONG WITH ADDED PROCEDURE TIME, EXTENDED RECOVERY, ETC. ADDITIONAL INFORMATION: WE DO NOT KNOW WHICH TRAY WAS USED FOR WHICH CASE. WE KNOW OF 4 CASES IN TOTAL (B)(6) 2025. ONE OF THE CASES, THE MEDICATION DID NOT WORK AT ALL; THE OTHER 3, IT WORE OFF RAPIDLY. TWO CASES WERE ANECDOTALLY REPORTED AS ABOUT 20 MINUTES; THE OTHER CASE WAS NOT REPORTED (THE DURATION). TWO MOVED TO GENERAL ANESTHESIA, ONE TO AN EPIDURAL AND ONE WAS ABLE TO BE MANAGED WITH ADDITIONAL MEDICATION. AT THIS POINT, A 5TH CASE HAS NOT BEEN CONFIRMED. WE HAVE ONLY THE THREE TRAYS WE HAD PREVIOUSLY REPORTED. (B)(6) 2025 - RESOLVED WITH

  Patient problems: Awareness During Anesthesia

  MAUDE report 22555641 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION: INEFFECTIVE ANESTHESIA, RESOLVED WITH ADDITIONAL MEDICATION. EVENT DETAILS: WE EXPERIENCED A TOTAL OF 5 FAILED SPINALS (4 WITHIN THE PAST WEEK, THE OTHER 1 EARLIER IN THE MONTH) AND ARE QUESTIONING THE EFFICACY OF THE INCLUDED MEDICATIONS AS THAT IS THE PRIMARY CONSISTENT FACTOR DURING THESE EVENTS THAT OCCURRED. WE ARE STILL CONFIRMING THE NUMBER OF REPORTS AND VERIFYING NONE OF THESE HAVE BEEN DUPLICATED, BUT THIS IS THE DETAIL WE HAVE RECEIVED SO FAR. NO SPECIFIC PATIENT HARM WAS REPORTED, ALTHOUGH CONVERSION TO GENERAL ANESTHESIA WAS REQUIRED SO THE ASSOCIATED ADDITIONAL RISKS THAT GO ALONG WITH ADDED PROCEDURE TIME, EXTENDED RECOVERY, ETC. ADDITIONAL INFORMATION: WE DO NOT KNOW WHICH TRAY WAS USED FOR WHICH CASE. WE KNOW OF 4 CASES IN TOTAL ON (B)(6) 2025. ONE OF THE CASES THE MEDICATION DID NOT WORK AT ALL THE OTHER 3 IT WORE OFF RAPIDLY. TWO CASES WERE ANECDOTALLY REPORTED AS ABOUT 20 MINUTES; THE OTHER CASE WAS NOT REPORTED THE DURATION. TWO MOVED TO GENERAL ANESTHESIA, ONE TO AN EPIDURAL AND ONE WAS ABLE TO BE MANAGED WITH ADDITIONAL MEDICATION. AT THIS POINT A 5TH CASE HAS NOT BEEN CONFIRMED. WE HAVE ONLY THE THREE TRAYS WE HAD PREVIOUSLY REPORTED. ON (B)(6)

  Patient problems: Awareness During Anesthesia

  MAUDE report 22555628 ↗
• MalfunctionApr 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED WHILE USING BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH L THE MEDICATION WAS INEFFECTIVE. THIS OCCURRED 6 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER SEVERAL FAILED SPINALS.   "WE HAVE HAD SEVERAL (APPROX. 5) FAILED SPINALS USING THE BUPIVICAINE OUT OF THE BD SPINAL ANESTHESIA TRAYS, "WE HAVE ANOTHER POSSIBLE FAILED SPINAL FROM A SPINAL ANESTHESIA TRAY USED TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14242628 ↗
• MalfunctionApr 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED WHILE USING BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH THE ANESTHESIA WAS INEFFECTIVE. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER 5 FAILED SPINALS FROM BD SPINAL TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110215 ↗
• MalfunctionMar 11, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SPINAL ANESTHESIA TRAY CONTAINED LESS MEDICATION THAN EXPECTED THREE TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "BD SPINAL ANESTHESIA TRAY- SHOULD CONTAIN 15MG BUT HE SUSPECTS IT IS CLOSER TO 5-6MG. WE HAVE A PHYSICIAN QUESTIONING THE QUANTITY OF BUPIVACAINE IN THE VIALS INCLUDED IN THE KIT. HE STATED EACH VIAL SHOULD CONTAIN 15MG BUT HE SUSPECTS IT IS CLOSER TO 5-6MG. HE REFERENCED 3 STRAIGHT CASES WHERE THIS LOT NUMBER WAS PROBLEMATIC. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13741990 ↗
• MalfunctionDec 28, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT WHILE USING BD¿ SPINAL ANESTHESIA TRAYS, THE SURGICAL BLOCK WAS INEFFECTIVE DURING SURGERY. THIS EVENT OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE LAST THREE ATTEMPTS FAILED WITH THE KIT, PATIENT REPORTED LEGS WERE HEAVY BUT SURGICAL BLOCK WAS NOT ADEQUATE FOR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13098846 ↗
• MalfunctionMar 29, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT TRAY SPN WHIT25G3.5 L/B-D/E WAS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405673 BACK NO.: UNKNOWN (1387545 OR 1370473. IT WAS REPORTED THAT THE ANESTHESIA IN THE TRAYS ARE NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586625 ↗
• MalfunctionMar 24, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT TRAY SPN WHIT25G3.5 L/B-D/E WERE NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405673 BACK. NO.: UNKNOWN (1387545 OR 1370473). IT WAS REPORTED THAT THE ANESTHESIA IN THE TRAYS ARE NOT WORKING. PER EMAIL: ORDERED A CASE OF SPINAL TRAYS AND THE CRNA IS TELLING ME THAT A FEW TRAYS OF THAT CASE WERE DEFECTED. SHE SAID THEY ARE HAVING TO CONVERT TO GENERAL ANESTHESIA B/C THE MEDICATION IN THESE KITS WERE NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565987 ↗
• MalfunctionSep 3, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT 4 TRAYS SPN WHIT25G3.5 L/B-D/E HAD INEFFECTIVE ANESTHESIA DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BY FAILURE WE MEAN WHILE PLACING THE SPINAL EVERYTHING SEEMED PERFECT BUT THE SPINAL DID NOT TAKE EFFECT PROPERLY. DR. SPINAL SET IN BUT THEN WORE OFF VERY QUICKLY. IN MY TWO ONE PATIENT HAD GOOD ANALGESIA AND WERE ABLE TO COMPLETE THE SURGERY BUT THEY COULD STILL MOVE THEIR SURGICAL LEG. IN ANOTHER ONE DERMATOME WASN'T NUMB BUT THE REST OF THE ABDOMEN WAS FOR A C-SECTION. I ALSO HAD ANOTHER PATIENT WITH A LOW SPINAL LEVEL WHERE I HAD SO SUPPLEMENT WITH KETAMINE. DR. ALSO HAD 2 FAILURES BUT I DON'T KNOW THE DETAILS. I THINK THERE IS SOMETHING WRONG WITH THE HYPERBARIC BUPIVACAINE INCLUDED IN THE KIT. ITS LIKE THE MEDICATION IS NOT THE CORRECT POTENCY SO THE PATIENTS ARE GETTING UNDER DOSED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10487969 ↗
• MalfunctionJun 25, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TRAY SPN WHIT25G3.5 L/B-D/E LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405673 , BATCH NO: 0001272264. IT WAS REPORTED THAT GLASS SYRINGE WAS LEAKING. TODAY WE HAVE A PROBLEM WITH ONE OF THE BD TRAY. THE GLASS SYRINGE WAS LEAKING AND DR. CALLED ME FOR HELP. THIS A BIG SAFETY ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731833 ↗