BD Luer-Lok, BD Glaspak 405637Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 50382904056372), received between Jun 25, 2019 and Jan 29, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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-2257-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Defective Component; Lack of Effect; Defective Component; Lack of Effect

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594595 ↗
• InjurySep 21, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TRAY SPN SPT24G3.5 L/B-D/E NEEDLE BROKE OFF DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405637, BATCH NO. 0001330369. IT WAS REPORTED THAT NEEDLE BROKE OFF DURING INJECTION. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: (B)(6) YEAR OLD FEMALE ADMITTED (B)(6) 2020 FOR PRE-ECLAMPSIA GESTATIONAL DIABETES MANAGEMENT ON (B)(6) 2020 DUE TO SEVERE PRE-ECLAMPSIA GOES TO OPERATING ROOM FOR C-SECTION. DURING SPINAL EPIDURAL TIP OF NEEDLE IS NOTICED TO BE BROKEN UPON REMOVAL. NEEDLE SEND TO PATHOLOGY. THE NEEDLE WAS REMOVED (B)(6) BY NEUROLOGIST IN THE OPERATING ROOM UNDER FLURO NEUROLOGIST SIGNED OFF (B)(6) THE PATIENT DISCHARGED (B)(6) SHE WAS UP AMBULATING WITH MINIMAL PAIN PER THE MD NOTE FDA SAFETY REPORT ID # (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 10564352 ↗
• InjurySep 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT TRAY SPN SPT24G3.5 L/B-D/E FAILED TO WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE MARCAINE IN THE SPINAL TRAY IS COMPROMISED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: THERE IS CONCERN THAT THESE LOTS HAVE ISSUES WITH THE MARCAINE THAT IS SUPPLIED IN THE TRAYS. THERE HAVE BEEN A FEW REPORTS. PT SCHEDULED FOR C-SECTION THIS AM WAS POSITIONED FOR A SPINAL IN OR. DR. ADMINISTERED SPINAL ANESTHESIA WITHOUT DIFFICULTY, WAS CONFIDENT IN PLACEMENT. PATIENT DID NOT RECEIVE ADEQUATE ANESTHESIA TO PROCEED WITH C-SECTION, CASE WAS CONVERTED TO GENERAL ANESTHESIA AND PROCEEDED WITHOUT INCIDENT. DR. WAS CONCERNED THAT THIS IS THE SECOND SUCH CASE IN 36 HOURS. HE HAD THE SAME INCIDENT ON A PATIENT ON (B)(6) AT 2100. AGAIN, DR. WAS CONFIDENT THE PLACEMENT WAS APPROPRIATE, BUT PATIENT DID NOT RECEIVE ADEQUATE ANESTHESIA FOR THE PROCEDURE AND REQUIRED GENERAL ANESTHESIA. DR. IS CONCERNED THAT THE MARCAINE IN THE SPINAL TRAYS IS COMPROMISED."

  Patient problems: Awareness During Anesthesia

  MAUDE report 10477828 ↗
• InjuryAug 31, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DIDN'T NOT RECEIVE ADEQUATE ANESTHESIA FROM TRAY SPN SPT24G3.5 L/B-D/E FOR THE PROCEDURE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405637, BATCH NO. 0001332520. IT WAS REPORTED THAT THE MARCAINE IN THE SPINAL TRAY IS COMPROMISED. EVENT DESCRIPTION PER EMAIL STATES: THERE IS CONCERN THAT THESE LOTS HAVE ISSUES WITH THE MARCAINE THAT IS SUPPLIED IN THE TRAYS. THERE HAVE BEEN A FEW REPORTS. PT SCHEDULED FOR C/SECTION THIS AM WAS POSITIONED FOR A SPINAL IN OR. DR. ADMINISTERED SPINAL ANESTHESIA WITHOUT DIFFICULTY, WAS CONFIDENT IN PLACEMENT. PATIENT DID NOT RECEIVE ADEQUATE ANESTHESIA TO PROCEED WITH C/SECTION, CASE WAS CONVERTED TO GENERAL ANESTHESIA AND PROCEEDED WITHOUT INCIDENT. DR. WAS CONCERNED THAT THIS IS THE SECOND SUCH CASE IN 36 HOURS. HE HAD THE SAME INCIDENT ON A PATIENT ON 6/14 AT 2100. AGAIN, DR. WAS CONFIDENT THE PLACEMENT WAS APPROPRIATE, BUT PATIENT DID NOT RECEIVE ADEQUATE ANESTHESIA FOR THE PROCEDURE AND REQUIRED GENERAL ANESTHESIA. DR. IS CONCERNED THAT THE MARCAINE IN THE SPINAL TRAYS IS COMPROMISED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 10471336 ↗
• MalfunctionApr 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT TRAY SPN SPT24G3.5 L/B-D/E MEDICATION WAS NOT EFFECTIVE. THIS OCCURRED ON 22 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405637 BATCH NO.: 0001330659. IT WAS REPORTED THE BUPIVACAINE IS NOT EFFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9914316 ↗
• MalfunctionDec 31, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT HAS BEEN REPORTED THAT THE BD¿ TRAY SPN SPT24G3.5 L/B-D/E HAS BEEN FOUND WITH INEFFECTIVE ANESTHESIA DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405637 BATCH NO.: 0001315906 & 000138731. IT WAS REPORTED THE PATIENTS ARE NOT GETTING GOOD MOTOR BLOCK AND MINIMAL SENSORY BLOCK RESULTING IN THEM HAVING TO REVERT TO GENERAL ANESTHESIA. VERBATIM: THE 2 ABOVE LOT #'S WERE USED (B)(6) 2019. PATIENTS ARE NOT GETTING GOOD MOTOR BLOCK & MINIMAL SENSORY BLOCK. ANESTHESIA IS HAVING TO REVERT TO GENERAL ON THESE AND OTHER CASES. THERE WERE A COUPLE OF CASES OVER THE WEEKEND & A COUPLE LAST WEEK.

  Patient problems: Underdose

  MAUDE report 9534180 ↗
• MalfunctionJun 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ANESTHESIA TREATMENT FAILURE OCCURRED DURING USE WITH TRAY SPN SPT24G3.5 L/B-D/E. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ANESTHESIA PERFORMED SPINAL WITHOUT DIFFICULTY - PATIENT NOT ANESTHETIZED - FAILED SPINAL WE HAVE HAD 6 SPINALS IN TWO DAYS THAT HAVE FAILED. KITS NOT KEPT, SO LOT NUMBER NOT CONFIRMED. PULLED BD KITS WITH ASSOCIATED LOT NUMBERS FROM SPD. WE BELIEVE THERE IS AN ISSUE WITH THE MARCAINE. PLEASE INVESTIGATE." 7 OCCURRENCES WERE REPORTED, BUT THE DATE/TIME AND PATIENT INFORMATION ARE NOT KNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732846 ↗