BD Luer-Lok, BD Glaspak 405735Recalls & reported problems
Becton, Dickinson And Company · TRAY SPN QNKE25G3.5 B-D/L/E/P · Class 2
All models of BD Luer-Lok, BD Glaspak (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50382904057355), received between Aug 15, 2023 and Jan 1, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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.
Reports received per month
Recalls naming this device
- 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-2249-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Patient-Device Incompatibility2
- Lack of Effect1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 1, 2025Lack of Effect; Lack of Effect
MATERIAL# 405735, BATCH# 0001547937. VERBATIM: PT WAS AN UNSCHEDULED CESAREAN SECTION FOR HELLP AT 25.2 WEEKS GESTATION. SPINAL WAS PLACED BY DR; PATIENT DID NOT GET NUMB. DR. STATED IT IS THE MEDICATION IN THE SPINAL TRAYS AND TO FIND ANOTHER LOT NUMBER. ANOTHER TRAY BY A DIFFERENT MANUFACTURER WAS FOUND AND THE SPINAL WAS EFFECTIVE. THE PATIENT HAD TO BE POKED TWICE DUE TO THE DEFECTIVE SPINAL TRAY. A GENERAL ON A 25.2 WEEK FETUS WOULD HAVE FURTHER COMPROMISED THE FETUS. THIS ALSO CAUSED A DELAY OF CARE AS THE PATIENT HAD A SECOND SPINAL PLACED AND HAD TO BE PREPPED AGAIN. ALSO NOTE THAT THE NICU TEAM HAD TO BE OFF THEIR UNIT FOR LONGER THAN EXPECTED DUE TO THE DELAY OF CARE. THE DEFECTIVE SPINAL TRAYS LOT # IS 0001547937. EVENT DATE: 12/23/2024 DESCRIPTION: TRAY SPINAL ANESTH 25G 3.5IN QNKE L/E/P SAMPLE AVAILABLE: YES (IF SAMPLE IS AVAILABLE AND WOULD LIKE IT SENT FOR YOUR EVALUATION, PLEASE REPLY ALL, AND ATTACH A RETURN SHIPPING LABEL VIA EMAIL) LOT #: 0001547937. WAS THERE INJURY? CAUSED THE PATIENT TO HAVE MULTIPLE STICKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21052138 ↗MalfunctionAug 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED BY CUSTOMER THAT THEY MULTIPLE FAILED SPINALS WITH A SPECIFIC LOT OF SPINAL KITS - WITHIN THOSE KITS IS BUPIVACAINE; THE SUGGESTION IS THIS MEDICATION IS DEFECTIVE AND INEFFECTIVE. VERBATIM: ISSUE: ANESTHESIA HAD MULTIPLE FAILED SPINALS WITH A SPECIFIC LOT OF SPINAL KITS - WITHIN THOSE KITS IS BUPIVACAINE; THE SUGGESTION IS THIS MEDICATION IS DEFECTIVE AND INEFFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17603969 ↗MalfunctionAug 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ SPINAL ANESTHESIA TRAYS' BUPIVACAINE FAILED TO WORK DURING THE SPINAL TREATMENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ISSUE: ANESTHESIA HAD MULTIPLE FAILED SPINALS WITH A SPECIFIC LOT OF SPINAL KITS - WITHIN THOSE KITS IS BUPIVACAINE; THE SUGGESTION IS THIS MEDICATION IS DEFECTIVE AND INEFFECTIVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17553230 ↗
Other Anesthesia conduction kit devices
- BD Luer-Lok, BD Glaspak 405671Becton, Dickinson And Company · Anesthesia conduction kit1 recall68 reports
- ARROW IPN922678Teleflex Incorporated · Anesthesia conduction kit2 recalls0 reports
- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- BD Glaspak 405675Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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