BD Luer-Lok, BD Glaspak 405699Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 50382904056990), received between Apr 17, 2018 and Apr 2, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21752660 ↗
• InjuryDec 11, 2023Lack of Effect; Lack of Effect

  MATERIAL#: 405699. BATCH NUMBER#: 0001524849. IT WAS REPORTED BY CUSTOMER THAT HAVING AN ISSUE WITH THE SPINAL TRAYS WITH THE LOT #0001524849. IT SEEMS THAT THE BUPIVACAINE HCL THAT IS IN THE TRAY IS THE PROBLEM. THE MEDICATION HAS NOT BEEN EFFECTIVE IN MULTIPLE CASES BETWEEN LAST WEEK AND THIS WEEK LEADING TO PATIENTS REQUIRING MORE MEDICATION OR EVEN GENERAL ANESTHESIA. DURING OUR INVESTIGATION, ANESTHESIA USED THE BUPIVACAINE STOCKED IN THE PYXIS VS THE BUPIVACAINE FROM THE TRAY AND THE ANESTHESIA WAS EFFECTIVE. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTED ISSUE PER CUSTOMER: "WE ARE HAVING AN ISSUE WITH THE SPINAL TRAYS WITH THE LOT #0001524849. IT SEEMS THAT THE BUPIVACAINE HCL THAT IS IN THE TRAY IS THE PROBLEM. THE MEDICATION HAS NOT BEEN EFFECTIVE IN MULTIPLE CASES BETWEEN LAST WEEK AND THIS WEEK LEADING TO PATIENTS REQUIRING MORE MEDICATION OR EVEN GENERAL ANESTHESIA.DURING OUR INVESTIGATION, ANESTHESIA USED THE BUPIVACAINE STOCKED IN THE PYXIS VS THE BUPIVACAINE FROM THE TRAY AND THE ANESTHESIA WAS EFFECTIVE." MEDLINE REFERENCE: (B)(4). ITEM: 405699. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO #: (B)(4). ARE ANY SAMPLES AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303162 ↗
• MalfunctionSep 3, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD SPINAL ANESTHESIA TRAY 27G X 3.5" WHITACRE SPINAL NEEDLE EXPIRED PRODUCT WAS RECEIVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL# 405699, BATCH# UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS AN EXPIRATION DATE ISSUE WITH THE CONTENTS OF THE TRAY. VERBATIM: WE HAVE HAD NURSES ON THE OB FLOOR OPEN TRAYS THAT ON THE OUTSIDE INDICATE THAT THEY ARE STILL WITHIN THE USABLE DATE. BUT UPON OPENING THEM, THE MARCAINE THAT COMES IN THE TRAYS ARE EXPIRED. THIS MAKES IT DIFFICULT FOR US TO KNOW WITHER THE TRAYS ARE GOOD TO USE AND WHAT WE WILL NEED TO GET RID OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353669 ↗
• MalfunctionJan 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE BD WHITACRE¿ SPINAL TRAY EXPERIENCED INEFFECTIVE ANESTHESIA THAT FAILED TO WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANESTHESIA DOESN'T FUNCTION IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13397163 ↗
• MalfunctionDec 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK PARTICLE OF FOREIGN MATTER WAS FOUND IN THE BD WHITACRE¿ SPINAL TRAY SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THAT ON (B)(6) 2021, THE ANESTHESIOLOGIST IS GIVING SPINAL ANESTHESIA TO A PATIENT, WHEN HE PREPARES THE SYRINGE WITH THE ANESTHETIC MEDICINE OF BUPIVACAINE, IS GOING TO ADMINISTER IT, OBSERVES THAT THE SYRINGE HAS A COLORED BLACK PARTICLE VISIBLE WITH MOVEMENT, HE SPECULATES THAT IT MIGHT BE FROM THE PLUNGER OF THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004331 ↗
• InjuryJul 1, 2021Break; Break

  IT WAS REPORTED THAT THE TRAY SPN WHIT27G3.5 L/B-D/E NEEDLE BROKE OFF FROM THE HUB WHILE PREPARING FOR A C -SECTION, WHICH HAD TO BE RETRIEVED BY AN ADDITIONAL PROCEDURE IN TERTIARY CARE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER RESPONSE: WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? SPINAL IN PREP FOR A C-SECTION. WHAT WAS THE ADDITIONAL PROCEDURE THAT WAS DONE TO RETRIEVE THE NEEDLE? THIS, I DO NOT HAVE THE INFORMATION. WHAT WAS THE PATIENT OUTCOME? REQUIRED TRANSFER TO TERTIARY CARE CENTER AND ADDITIONAL PROCEDURE." "THE NEEDLE IN THIS TRAY BROKE DURING THE PROCEDURE AND IT WAS NOT ABLE TO BE RETRIEVED WITHOUT AN ADDITIONAL PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 12104030 ↗
• InjurySep 4, 2020Break; Break

  IT WAS REPORTED THAT THE TRAY SPN WHIT27G3.5 L/B-D/E NEEDLE BROKE OFF IN THE PATIENT'S BACK DURING USE. AS A RESULT, THE PATIENT WILL BE RECEIVING A SURGERY CONSULTATION FOR REMOVAL OF THE NEEDLE UNDER FLUOROSCOPY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DR. REPORTS THAT THE NEEDLE BROKE INSIDE THE PATIENT'S BODY." "DURING A SPINAL ANESTHESIA ATTEMPT AS USUAL. NEEDLE BROKE, LEAVING ABOUT 1 1/2 INCH INSIDE PATIENTS BACK WHEN I RETRIEVED WITHOUT RESISTANCE. IS THE FIRST TIME IN 20 YEARS THAT HAPPEN TO ME. I BELIEVE NEEDLE. HAD SOME ISSUE OR ARE BROKEN." "NEED SURGERY CONSULT FOR OPEN REMOVAL OF NEEDLE TIP UNDER FLUOROSCOPY."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10496064 ↗
• MalfunctionApr 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT FAILED SPINAL BLOCKS OCCURRED WITH A TRAY SPN WHIT27G3.5 L/B-D/E. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ANESTHESIA DEPARTMENT EXPERIENCED 3 FAILED OR PARTIAL SPINAL BLOCKS IN A 16 HOUR PERIOD WITH THE BUPIVACAINE IN THE TRAY. CRNA'S WILL CONTINUE USING OUR TRAY BUT WILL PULL ANESTHETIC FROM PHARMACY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9930502 ↗
• MalfunctionAug 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE ANESTHESIA WAS INEFFECTIVE AND WORE OFF QUICKLY WITH A BD TRAY SPN WHIT27G3.5 L/B-D/E. THIS OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE ANESTHESIA WAS INEFFECTIVE AND WORE OFF QUICKLY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8865802 ↗
• MalfunctionJul 10, 2019Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT DURING USE THE MARCAINE IN THE ANESTHESIA TRAYS WERE INEFFECTIVE WITH A BD TRAY SPN WHIT27G3.5 L/B-D/E. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL COMPANY REPORTER: (3 OF 3) IT WAS REPORTED THAT THERE HAS BEEN ISSUES WITH THE MARCAINE IN THE ANESTHESIA TRAYS NOT PROPERLY WORKING AS NEEDED. THE INFORMATION PROVIDED BY DR. WAS AS FOLLOWS: 1. THURSDAY IN A CAESAREAN SECTION ADMINISTER THE MARCAINE THAT COMES IN THE TRAY, FOLLOWING THE STIPULATED PROCESS AND PATIENT CAN LIFT THE LEGS AND REPORT SENSATION IN THE AREA. HE OPENED ANOTHER TRAY AND REPEATED THE PROCESS, WITHOUT OBTAINING RESULTS. 2. ON SUNDAY, ANOTHER OF THE ANESTHESIOLOGISTS REPORTS THE SAME AND THE SAME RESULT WITH A PATIENT. 3. MONDAY IN AM DR. INDICATES THE SAME THING HAPPENS TO HIM, ALREADY AWARE OF THE EVENT IN THE AFTERNOON HE USES THE SPINAL BUPIVACAINE THAT WE HAVE IN THE PHARMACY ( DUE TO THE SHORTAGE THAT THERE WAS OF THE TRAYS WITH THE MARCAINA). NONE OF THE PATIENTS HAS TOLERANCE TO THE ANESTHESIA REPORTED. ON MONDAY AFTERNOON THE DOCTOR INDICATED THE PATIENT RESPONDED AS EXPECTED. AT THE MOMENT, THEY ARE USING THE TRAYS AND NOT THE MEDICATION IN THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776594 ↗
• MalfunctionJul 10, 2019Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT THE MARCAINE IN THE BD¿ SPINAL ANESTHESIA TRAY WAS NOT WORKING PROPERLY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405699 BATCH NO. 0001270921 IT WAS REPORTED THAT THERE HAS BEEN ISSUES WITH THE MARCAINE IN THE ANESTHESIA TRAYS NOT PROPERLY WORKING AS NEEDED. PER EMAIL: THE INFORMATION PROVIDED WAS AS FOLLOWS: 1. THURSDAY IN A CAESAREAN SECTION ADMINISTER THE MARCAINE THAT COMES IN THE TRAY, FOLLOWING THE STIPULATED PROCESS AND PATIENT CAN LIFT THE LEGS AND REPORT SENSATION IN THE AREA. HE OPENED ANOTHER TRAY AND REPEATED THE PROCESS, WITHOUT OBTAINING RESULTS. 2. ON SUNDAY, ANOTHER OF THE ANESTHESIOLOGISTS REPORTS THE SAME AND THE SAME RESULT WITH A PATIENT. 3. ON MONDAY, INDICATES THE SAME THING HAPPENS TO HIM, ALREADY AWARE OF THE EVENT IN THE AFTERNOON HE USES THE SPINAL BUPIVACAINE THAT WE HAVE IN THE PHARMACY ( DUE TO THE SHORTAGE THAT THERE WAS OF THE TRAYS WITH THE MARCAINA). NONE OF THE PATIENTS HAS TOLERANCE TO THE ANESTHESIA REPORTED. ON MONDAY AFTERNOON THE DOCTOR INDICATED THE PATIENT RESPONDED AS EXPECTED. AT THE MOMENT, THEY ARE USING THE TRAYS AND NOT THE MEDICATION IN THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8775828 ↗
• MalfunctionJul 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT 2 TRAY SPN WHIT27G3.5 L/B-D/E EXPERIENCED INEFFECTIVE ANESTHESIA WITH THE TREATMENT FAILING TO WORK. PRODUCT DEFECT OCCURRED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405699, BATCH NO. 0001270921. PER EMAIL: THE INFORMATION PROVIDED BY PHYSICIAN WAS AS FOLLOWS: IN A CAESAREAN SECTION ADMINISTER THE MEDICATION THAT COMES IN THE TRAY, FOLLOWING THE STIPULATED PROCESS AND PATIENT CAN LIFT THE LEGS AND REPORT SENSATION IN THE AREA. HE OPENED ANOTHER TRAY AND REPEATED THE PROCESS, WITHOUT OBTAINING RESULTS. ON SUNDAY, ANOTHER OF THE ANESTHESIOLOGISTS REPORTS THE SAME AND THE SAME RESULT WITH A PATIENT. ANOTHER PHYSICIAN INDICATED THE SAME THING HAPPENED TO HIM, ALREADY AWARE OF THE EVENT IN THE AFTERNOON HE USES THE SPINAL ANESTHETIC THAT WE HAVE IN THE PHARMACY (DUE TO THE SHORTAGE THAT THERE WAS OF THE TRAYS). NONE OF THE PATIENTS HAD TOLERANCE TO THE ANESTHESIA REPORTED. ON THE FOLLOWING MONDAY AFTERNOON THE DOCTOR INDICATED THE PATIENT RESPONDED AS EXPECTED. AT THE MOMENT, THEY ARE USING THE TRAYS AND NOT THE MEDICATION IN THEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8775402 ↗
• MalfunctionJul 8, 2019Measurement System Incompatibility; Measurement System Incompatibility

  IT WAS REPORTED THAT TREATMENT FAILURE OCCURRED AFTER USE WITH TRAY SPN WHIT27G3.5 L/B-D/E. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I¿VE HAD COMPLAINTS ABOUT TWO FAILED SPINALS FROM THE SAME LOT NUMBER. I PULLED THE REST OF THE TRAYS OFF OUR SHELF WITH THIS LOT NUMBER." 2 OCCURRENCES WERE REPORTED, BUT THE DATE AND TIME AND PATIENT INFORMATION WERE NOT GIVEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8769673 ↗
• InjuryApr 17, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE MARCAINE IN THE BD SPINAL ANESTHESIA TRAY WAS NOT EFFECTIVE. THE DOCTOR SAID THE MARCAINE DID NOT WORK ON THE PATIENT AND THE PATIENT FELT THE ENTIRE SURGERY. HE IS TRYING AGAIN TO SEE IF IT WAS JUST THAT ONE TIME OR MULTIPLE IN THE LOT. OBSERVED DURING USE. MEDICAL INTERVENTION REQUIRED. CHANGE IN TREATMENT PLAN, DOCTOR (B)(6) PROVIDED LOCAL ANESTHETIC, IV MORPHINE AND PROPOFOL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7437122 ↗