BD Spinal Anesthesia Tray 400866Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 50382904008661), received between Nov 22, 2019 and Sep 4, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED PATIENT DID NOT HAVE ADEQUATE NUMBING AND FELT DISCOMFORT DURING THE SURGERY. EVENT DESCRIPTION: THE TRAY THEY USED WAS REF 400866 LOT 0001622776. THERE WAS AN INCIDENT WHEN THIS TRAY WAS USED FOR SPINAL ANESTHESIA PRIOR TO A CESAREAN DELIVERY, AND THE PATIENT DID NOT HAVE ADEQUATE NUMBING AND FELT DISCOMFORT DURING THE SURGERY. SEDATION WAS NECESSARY FOR THE SURGERY, AND THE PATIENT EXPERIENCED 10 OUT OF 10 PAIN IMMEDIATELY FOLLOWING THE PROCEDURE, AND REQUIRED USE OF A PCA PUMP.

  Patient problems: Awareness During Anesthesia

  MAUDE report 22963527 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION: FAILED MEDICATION, CONVERTED TO GENERAL ANESTHESIA. EVENT DETAILS: WE EXPERIENCED A TOTAL OF 5 FAILED SPINALS (4 WITHIN THE PAST WEEK, THE OTHER 1 EARLIER IN THE MONTH) AND ARE QUESTIONING THE EFFICACY OF THE INCLUDED MEDICATIONS AS THAT IS THE PRIMARY CONSISTENT FACTOR DURING THESE EVENTS THAT OCCURRED. WE ARE STILL CONFIRMING THE NUMBER OF REPORTS AND VERIFYING NONE OF THESE HAVE BEEN DUPLICATED, BUT THIS IS THE DETAIL WE HAVE RECEIVED SO FAR. NO SPECIFIC PATIENT HARM WAS REPORTED, ALTHOUGH CONVERSION TO GENERAL ANESTHESIA WAS REQUIRED SO THE ASSOCIATED ADDITIONAL RISKS THAT GO ALONG WITH ADDED PROCEDURE TIME, EXTENDED RECOVERY, ETC. ADDITIONAL INFORMATION WE DO NOT KNOW WHICH TRAY WAS USED FOR WHICH CASE. WE KNOW OF 4 CASES IN TOTAL (B)(6) 2025. ONE OF THE CASES THE MEDICATION DID NOT WORK AT ALL THE OTHER 3 IT WORE OFF RAPIDLY. TWO CASES WERE ANECDOTALLY REPORTED AS ABOUT 20 MINUTES; THE OTHER CASE WAS NOT REPORTED THE DURATION. TWO MOVED TO GENERAL ANESTHESIA, ONE TO AN EPIDURAL AND ONE WAS ABLE TO BE MANAGED WITH ADDITIONAL MEDICATION. AT THIS POINT A 5TH CASE HAS NOT BEEN CONFIRMED. WE HAVE ONLY THE THREE TRAYS WE HAD PREVIOUSLY REPORTED. (B)(6) 2025 - RESOLVED

  Patient problems: Awareness During Anesthesia

  MAUDE report 22554940 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873100 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873097 ↗
• MalfunctionFeb 19, 2025Lack of Effect; Lack of Effect

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410423 ↗
• InjuryFeb 19, 2025Lack of Effect; Lack of Effect

  MATERIAL # 400866 , BATCH #0001566190. VERBATIM: CUSTOMER REPORTS THAT THE NEEDLE FAILED, RESULTING IN AN INCOMPLETE PROCEDURE. THE CUSTOMER STATES, ¿THE BUPIVACAINE HAS CAUSED A SERIES OF INCOMPLETE SPINALS¿ THAT BLOCK IS PRETTY DEFINITIVE AS CSF FLOWS BACK IN THE NEEDLE, SO UNLIKELY TO BE USER ERROR.¿ CUSTOMER RESPONSE RECEIVED ON (B)(6) 2025: I DON¿T THINK THE NEEDLE WAS THE ISSUE HERE. IT WAS LIKELY THE BUPIVACAINE THAT WAS RESULTING IN A SERIES OF INCOMPLETE BLOCKS. ADDING DR. HAND FOR ADDITIONAL DETAILS. CUSTOMER RESPONSE RECEIVED ON (B)(6) 2025: 1.WHEN REPORTED "THE BUPIVACAINE HAS CAUSED A SERIES OF INCOMPLETE SPINALS" - DOES THAT MEAN THE ANAESTHESIA IS NOT NUMBING THE PATIENT? OR IS THERE AN ISSUE WITH THE NEEDLE ADMINISTERING? THE PATIENTS ARE NOT BECOMING ¿NUMB¿ AS WOULD BE EXPECTED WITH A SPINAL DOSE OF BUPIVACAINE. ONE PATIENT HAD LITTLE TO NO NUMBNESS DESPITE APPROPRIATE FLOW OF CSF OUT OF THE NEEDLE. 2. ARE THEY COMPLETING THE PROCEDURE USING A NEW VIAL OF MEDICATION OR REVERTING TO GENERAL ANAESTHESIA? IN BOTH CASES, THE PATIENTS HAD TO HAVE GENERAL ANESTHESIA, A FAR INFERIOR ANESTHETIC FOR A C-SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410221 ↗
• MalfunctionSep 16, 2024Lack of Effect; Lack of Effect

  MATERIAL# 400866 BATCH# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PATIENT TAKEN TO OR. SAB (SUBACRACHNOID BLOCK AKA SPINAL) PLACED WITH PRE AND POST "SWIRL" OF 1.2CC 0.75% BUPIV. FROM KIT WITH 250MG DURAMORPH, PATIENT NOTED BOTTOM ARM AND GETTING NUMB (SPANISH SPEAKING BUT ABLE TO INDICATE UNTIL INTERPRETER COMMUNICATION ESTABLISHED). PATIENT INDICATED PRESSURE BUT NO PAIN WITH FOLEY BUT NOTED COLD WITH ALCOHOL USED TO WIPE OFF JELLY FOR FETAL HEART TONES (FIRST INDICATION OF ISSUES), WITH PREP PATIENT NOTED A DIFFERENCE IN TEMPERATURE AT APPROXIMATELY T-10, AFTER DRAPING PATIENT NOTED A GOOD AMOUNT OF PRESSURE ON LEFT BUT PAIN ON MIDLINE (LUD POSITION), OPTION OF GETA OR EPIDURAL GIVEN AND PATIENT AUTOMATICALLY ELECTED EPIDURAL SO WE SAT HER UP AND THE SURGEON¿S (NEW XX DOCTOR) AND BARD HELD HER AND EPIDURAL PLACED AT SAME LEVEL WITH OUT DIFFICULTY, DOSED WITH 10CC 2% WITH LIDO. WITH EPI AND BICARBONATE, PATIENT HAD SURGICAL BLOCK BY THE TIME WE WERE DRAPED AGAIN. ALL THIS WITH A NEW SURGEON (WITH BARD ASSISTING AND WOOD OBSERVING" FOR CREDENTIALING) THIS WAS ALL DONE WITH THE BABY OUT AND THE UTERUS CLOSED, NOT FASCIA THOUGH, BY 9AM AND I DON¿T BELIEVE WE WERE IN THE ROOM TILL 7:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224187 ↗
• InjuryJan 17, 2024Lack of Effect; Lack of Effect

  MATERIALS#: 400866 BATCH#: 0001517987. IT WAS REPORTED BY THE CUSTOMER THAT SPINAL ANESTHESIA WAS INADEQUATE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DESCRIBE EVENT OR PROBLEM: PATIENT SCHEDULE FOR ELECTIVE POST-PARTUM TUBAL LIGATION UNDER SPINAL ANESTHESIA. PROCEDURE DESCRIBED IN PSE AS EASY SPINAL WITH EASY ASPIRATION PRIOR TO AND AFTER INJECTION OF INTRATHECAL ANESTHETIC (BUPIVACAINE 0.75% WITH DEXTROSE 8.25%). DESPITE TYPICAL DOSE USED (12 MG), TRENDELLENDERG POSITION, AND ADEQUATE TIME USED TO SET UP, SPINAL ANESTHESIA WAS INADEQUATE. PATIENT BECAME VERY ANXIOUS AND DECISION TO PROCEED TO GETA WAS MADE. DATE OF EVENT: 30-NOV-2023.

  Patient problems: Anxiety

  MAUDE report 18528188 ↗
• MalfunctionFeb 8, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED WHILE USING BD SPINAL ANESTHESIA TRAY - BD WHITACRE SPINAL NEEDLE THE ANESTHESIA DID NOT WORK PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEY HAD 1 TRAYS PN 400866, LOT 1439606 HERE THE DRUG WAS NOT WORKING. THEY REPORTED GOOD SPINAL RETURN BUT LACK OF EFFICACY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318631 ↗
• MalfunctionFeb 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED WHILE USING BD SPINAL ANESTHESIA TRAY - BD WHITACRE SPINAL NEEDLE THE ANESTHESIA DID NOT WORK PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THEY HAD 1 TRAYS HERE THE DRUG WAS NOT WORKING. THEY REPORTED GOOD SPINAL RETURN BUT LACK OF EFFICACY. NO INJURY REPORTED. THEY ONLY HAVE 1 DATE OF OCCURRENCE 1 TRAY AFFECTED (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16317204 ↗
• MalfunctionSep 16, 2020Therapeutic or Diagnostic Output Failure

  INCIDENT DESCRIPTION: FAILED SPINAL - POSITIVE CEREBROSPINAL FLUID (CSF) ASPIRATION, 1.8ML 0.75% MARCAINE, 200 MCG DURAMORPH, 10 MCG FENTANYL GIVEN AFTER POSITIVE CSF ASPIRATION. AFTER MEDICATIONS WERE INJECTED, AGAIN POSITIVE ASPIRATION WAS NOTED AS WELL. SPINAL NOT ADEQUATE FOR SURGERY - GENERAL ANESTHESIA NEEDED. 0.75% MARCAINE, MANUFACTURED BY BAXTER, LOT# A0C0091. NOTE FROM THE OPERATIVE REPORT: "THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SPINAL ANESTHESIA WAS ADMINISTERED, BUT WAS NOT ADEQUATE TO CONTROL THE PAIN. SHE HAD TO BE CONVERTED TO GENERAL." THERE WERE NO COMPLICATIONS NOTED. NOTE: THE TOP LABEL OF THE PACKAGE WAS NOT SAVED; UNKNOWN MANUFACTURER OF SPINAL TRAY. THE SIDE OF THE SPINAL TRAY HAD THE REFERENCE NUMBERS BUT NO PRODUCT NAME.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10539831 ↗
• MalfunctionNov 22, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT INEFFECTIVE ANESTHESIA OCCURRED DURING USE WITH A 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT 2 MORE C/ SECTIONS WITH THE INCIDENT DATE UNKNOWN TOOK PLACE AND WERE PERFORMED WHERE THE CRNA HAD ISSUE WITH THE SPINALS ANESTHESIA- BUPIVACAINE BEING QUESTIONABLE AS INEFFECTIVE (LOT # 0001280749). THEN A WEEK LATER 2 MORE C/ SECTIONS WERE PERFORMED, DATE OF INCIDENT FOR THIS EVENT IS UNKNOWN AT THE MOMENT AND IT INVOLVED TWO LOT NUMBERS (0001284188 & 0001301412). PER EMAIL: HI, HERE IS THE INFORMATION FOR THE COMPLAINT. DO YOU WANT TO ADD THIS TO THE EXISTING PR OR CREATE A NEW ONE? AT THIS TIME WE ONLY HAVE THE TRAY LOT INFORMATION, WE DO NOT HAVE THE DRUG LOT INFORMATION. RECENTLY STARTED USING NEW BD SPINAL KITS (PREVIOUSLY ARROW). LAST WEEK, OB HAD TWO C/SECTIONS IN WHICH THE SPINALS DIDN¿T TAKE. BOTH SPINALS WERE PUT IN BY THE SAME CRNA. THE FIRST C/S, HE REPEATED THE SPINAL WHICH PROVIDED THE PATIENT RELIEF. THE 2ND C/S, HE GAVE ADDITIONAL IV MEDS. A SAFETY OPPORTUNITY WAS ENTERED FOR THIS, AND AFTER DISCUSSING THESE CASES WITH THE CRNA, WE THOUGHT MAYBE THE MEDICATION WITHIN THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9364281 ↗