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BD Luer-Lok, BD Glaspak 405609Recalls & reported problems

Becton, Dickinson And Company · TRAY SPN QNKE22G3.5 L/B-D/E · Class 2

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 50382904056099), received between Jun 14, 2019 and Oct 28, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 27, 2026Open, 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-2248-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Device Markings/Labelling Problem1
  • Leak/Splash1
  • Patient-Device Incompatibility1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 28, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT INEFFECTIVE ANESTHESIA OCCURRED DURING USE WITH A TRAY SPN QNKE22G3.5 L/B-D/E. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HEALTH PROFESSIONAL REPORTED THAT THE DRUG BUPIVACAINE IN SEVERAL OF THE TRAYS WAS NOT WORKING. THIS DID OCCUR ON PATIENTS OCCURRED AT LEAST 4 SEPARATE INSTANCES." 4 OCCURRENCES WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9245634 ↗
  • MalfunctionAug 15, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT THE TRAY SPN QNKE22G3.5 L/B-D/E LABEL DID NOT STATE THAT IT CONTAINED BUPIVACAINE, WHILE ANOTHER TRAY LABEL DID. THE MISSING INFORMATION WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HEALTH PROFESSIONAL STATED THAT SHE HAS TWO OF THE SAME 405609 TRAY (WAS NOT PROVIDED LOT # BUT SAID IT COULD BE OBTAINED) AND ONE LABEL STATED IT CONTAINS BUPIVACAINE WHILE THE OTHER DID NOT SAY THIS."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8897949 ↗
  • MalfunctionJun 14, 2019Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT THETRAY SPN QNKE22G3.5 L/B-D/E EXPERIENCED TIP/LUER SYRINGE BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405609, BATCH NO. 0001275414. CN CALLED STATING THAT THE GLASS SYRINGE TIP OF THE ANAETHASIA TRAY CAT NO. 405609, LOT NO. OOO1275414, BROKE OFF AT THE TIP DURING USE. NO INJURY OR HARM, PRODUCT DID NOT TOUCH PATIENT, DATE OF INCIDENT (B)(6) 2019.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8700744 ↗

Other Anesthesia conduction kit devices

All Anesthesia conduction kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.