BD Luer-Lok, BD Glaspak 405707Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 50382904057072), received between Mar 4, 2019 and Apr 30, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ANESTHESIA WAS INEFFECTIVE WITH A BD TRAY SPN SPT24G3.5 B/L/E. THIS OCCURRED ON 5 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 5 TRAYS HAD INEFFECTIVE MEDICATION. ADDITIONALLY, ON 4/16/2020 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID ALL 5 INCIDENTS OCCUR ON THE SAME DAY? YES. ARE YOU ABLE TO PROVIDE PATIENT IDENTIFIERS? APART FROM THEY ALL OCCURRED IN OUR LABOR AND DELIVERY FLOOR, I CAN NOT. WAS THERE SERIOUS INJURY? AS FAR AS I HAVE HEARD, NO. WERE THERE ERRONEOUS RESULTS? YES, THE MEDICATION BUPIVACAINE WAS INEFFECTIVE WHEN ADMINISTERED. DID THE COURSE OF TREATMENT CHANGE? YES, THE ANESTHESIOLOGISTS HAD TO SUPPLY BUPIVACAINE FROM OUR OWN PYXIS STATION. WAS THERE EXPOSURE TO BLOOD/BODILY FLUID? AS FAR AS I HAVE HEARD, NO. WERE THERE ANY OTHER ACTIONS TAKEN? WE NOTIFIED OUR SUPPLIER TO GET A DIFFERENT LOT NUMBER CASE SENT (WE HAVE YET TO HEAR BACK) WILL SAMPLES BE RETURNING FOR INVESTIGATION? I ASSUME YOU MEAN A SAMPLE TRAY, IN WHICH CASE YES. I WOULD ALSO LIKE TO GET THE 3 UNOPENED CASES (30 TRAYS) WE HAVE REPLACED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10015601 ↗
• MalfunctionAug 5, 2019Break; Break

  IT WAS REPORTED THAT AFTER REMOVING THE TRAY SPN SPT24G3.5 B/L/E FROM THE PATIENT AFTER THE SPINAL PROCEDURE, THE HUB DISLODGED AND THE SPROTTE SPINAL NEEDLE REMAINED PARTIALLY INSIDE THE PATIENT, LEAKING FLUID FROM THE BACK. THE NEEDLE WAS REMOVED WITH NO REPORTED ADVERSE EFFECTS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS THE DOCTOR WAS REMOVING THE INTRODUCER FROM THE PATIENT AFTER HER SPINAL PROCEDURE, THE HUB CAME DISLODGED AND THE SPROTTE SPINAL NEEDLE PARTIALLY REMAINED IN THE PATIENT, DRIPPING FLUID FROM THE BACK. SHE WAS ABLE TO GRASP AND REMOVE THE NEEDLE, AND NO ADVERSE AFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE INCIDENT. THE ANESTHESIA TECH HAS ALSO REPORTED INSTANCES OF THESE NEEDLES BENDING.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8861280 ↗
• MalfunctionAug 5, 2019Break; Break

  IT WAS REPORTED THAT THE TRAY SPN SPT24G3.5 B/L/E EXPERIENCED A NEEDLE THAT BROKE/PULLED OUT OF THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405707 BATCH NO.: 0001260927. AS PHYSICIAN REMOVED THE INTRODUCER FROM THE PATIENT AFTER HER SPINAL PROCEDURE, THE HUB CAME DISLODGED AND THE SPINAL NEEDLE PARTIALLY REMAINED IN THE PATIENT, DRIPPING FLUID FROM THE BACK. SHE WAS ABLE TO GRASP AND REMOVE THE NEEDLE, AND NO ADVERSE AFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE INCIDENT. THE ANESTHESIA TECH HAS ALSO REPORTED INSTANCES OF THESE NEEDLES BENDING.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8859649 ↗
• MalfunctionMar 4, 2019Component Missing

  IT WAS REPORTED THAT THE TRAY SPN SPT24G3.5 B/L/E CAUSED A PATIENT TO BE TRANSFERRED TO ANOTHER HOSPITAL WHEN "THE TRAY WAS MISSING BUPIVACAINE AND MARCAINE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8388227 ↗