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BD Luer-Lok, BD Glaspak 405672Recalls & reported problems

Becton, Dickinson And Company · TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE · 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.

Quick summary

This BD spinal anesthesia kit is used to deliver spinal anesthetic during procedures. Its 24 reports mostly describe the anesthetic not working or providing inadequate pain relief, sometimes requiring a different anesthetic; some also mention torn packaging or contamination. The reports mention 13 injuries and no deaths. It has 1 open recall, started in April 2026, involving bupivacaine quality issues related to manufacturing acceptance testing.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
27
Deaths reported
0
Injuries reported
16
Recalls naming it
1

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 50382904056723), received between Dec 20, 2018 and Sep 15, 2026 — classified as 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (11 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 3 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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-2255-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Device problems

  • Patient-Device Incompatibility11
  • Lack of Effect4
  • Defective Device3
  • Therapeutic or Diagnostic Output Failure3
  • Appropriate Device Problem Term/Code Not Available2
  • Adverse Event Without Identified Device or Use Problem1
  • Defective Component1
  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Known Impact Or Consequence To Patient10
  • Awareness During Anesthesia6
  • No Clinical Signs, Symptoms or Conditions4
  • Inadequate Pain Relief2
  • Therapeutic Effects, Unexpected2
  • High Blood Pressure/ Hypertension1
  • Insufficient Information1
  • No Code Available1

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

  • InjurySep 15, 2026Lack of Effect

    Patient problems: Awareness During Anesthesia

    MAUDE report 50779016 ↗
  • InjurySep 15, 2026Lack of Effect

    It was reported, Spinal tray, failed spinal, reverted to general anesthesia. Patient 2 of 3.The following was provided by the initial reporter: I am reaching out as our OR team advised yesterday that they reported 4 failed spinals in the past couple days due to the marcaine in these 405672 trays not working. Trays were ordered under purchase order (b)(4) and LOT of the trays was reported to be B01W139D with the LOT of the faulty marcaine ((b)(6)) in those trays being LP8046. I did try to file a case on the Customer Care portal however that kept giving me an error when trying to submit without telling me what the error was. Please let us know if there is any other information needed in order to investigate this.Additional information:Can you please confirm an exact date of event in format dd-mmm-yyyy? 19-Aug-2026 and 18-Aug-2026.Can you please provide the Lot number associated with reported issue? Item 405672 has a LOT B01W139D, marcaine contained in the kit (Hospira (b)(6)) that was reported to have failed has a LOT LP8046.Any sample or photo available for investigation: No.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event: 4

    Patient problems: Awareness During Anesthesia

    MAUDE report 50779014 ↗
  • InjurySep 15, 2026Lack of Effect

    Patient problems: Awareness During Anesthesia

    MAUDE report 50779009 ↗
  • InjuryMar 11, 2024Lack of Effect; Lack of Effect

    ADDITIONAL INFORMATION: 5. HOW WAS THE ISSUE RESOLVED? ALL SPINAL TRAYS WITH THE AFFECTED LOT NUMBER WERE PULLED FROM OUR ORS AND GIVEN TO OUR FACILITY MATERIALS MANAGEMENT TEAM 6. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? STEVE MAY BE ABLE TO PROVIDE THIS IMAGE. LOT NUMBERS ARE: 0001525982 PLUS ONE WITH ONLY THE FRONT . I HAVE 3 SAMPLES THAT CAN BE SENT BACK.. OUR ADDRESS IS: (B)(6).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18874503 ↗
  • MalfunctionOct 18, 2023Packaging Problem; Packaging Problem

    MAT#: 405672; BATCH#: 0001515524. IT WAS REPORTED BY CUSTOMER THAT THERE WAS TEAR IN THE INTERNAL PACKAGING OF THE TRAY. VERBATIM: TEAR IN THE INTERNAL PACKAGING OF THE TRAY ADDITIONAL INFORMATION: 17OCT2023 DATE OF EVENT: 10/10/2023. HOW MANY OCCURRENCES OF DEFECTIVE SET(S) AFFECTED? ONE. WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? BEFORE. NOTICED WHEN OUTER PACKAGING WAS OPENED. WAS THERE ANY PATIENT INVOLVEMENT? NO. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. WHAT WAS THE PATIENT OUTCOME? NOTHING NEGATIVE. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? DELAY AS TOOK TIME TO GET ANOTHER SPINAL TRAY. WHAT PROCEDURE WAS BEING PERFORMED? LEFT TOTAL KNEE. WHAT MEDICATION WAS USED IN THE PROCEDURE? BUPIVACAINE FROM TRAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17956856 ↗
  • MalfunctionOct 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PIECE OF FIBER IN THE SYRINGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17914634 ↗
  • MalfunctionSep 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT THE TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE WAS INEFFECTIVE, AND THE TREATMENT FAILED TO WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WERE SEVERAL CONSECUTIVE FAILED SPINAL ANESTHETICS ON OB. CONSISTENT FACTOR HAS BEEN USING THE SPINAL BUPIVACAINE (0.75%) FROM THE KITS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12475278 ↗
  • MalfunctionDec 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA WAS INEFFECTIVE. THIS OCCURRED ON 8 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405672 BATCH NO: 0001378841. IT WAS REPORTED THAT: SOME OF THE BUPIVICAINE 0.75% FROM THE KITS WERE INEFFECTIVE. EVENT DESCRIPTION PER EMAIL STATES: ONE OF THE ANESTHESIA NURSES ALERTED ME THIS MORNING OF A PROBLEM WITH SOME OF THE SPINAL KITS. SHE SAID THAT SOME OF THE BUPIVICAINE 0.75% IS NOT WORKING ON PATIENTS AND THEY ARE NOW PULLING THAT OUT OF THE PYXIS, SO WE ARE WASTING THE BUPIVICAINE IN THE KITS. SHE WAS UNABLE TO RETRIEVE BECAUSE THE ANESTHESIOLOGISTS HAVE BEEN THROWING THE KITS INTO THE SHARPS BUCKETS. SHE KNOWS OF 6 OR 8 KITS WITH ISSUES, {IN A COUPLE LOCATIONS}.

    Patient problems: Awareness During Anesthesia; Insufficient Information

    MAUDE report 10929859 ↗
  • MalfunctionOct 21, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT THE TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE EXPERIENCED INEFFECTIVE ANESTHESIA, FAILING TO WORK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405672 BATCH NO. 0001283016. TWO PATIENTS ON (B)(6) 2020, RECEIVED PRE-PROCEDURE SPINAL ANESTHESIA WHICH WAS INEFFECTIVE AND ANOTHER TYPE OF ANESTHESIA HAD TO UTILIZED BY THE MEDICAL PROVIDER.

    Patient problems: Awareness During Anesthesia

    MAUDE report 10709388 ↗
  • InjuryOct 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT 2 TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE EXPERIENCED INEFFECTIVE ANESTHESIA -TREATMENT FAILED TO WORK DURING USE. PRODUCT DEFECT RESULTED IN MEDICAL INTERVENTION WITH A CHANGE IN TREATMENT, (GENERAL ANESTHESIA). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405672 BATCH NO. 0001283016 TWO PATIENTS ON 8/11/20, RECEIVED PRE-PROCEDURE SPINAL ANESTHESIA WHICH WAS INEFFECTIVE AND ANOTHER TYPE OF ANESTHESIA HAD TO UTILIZED BY THE MEDICAL PROVIDER. SEQUESTERED TRAY AND SPINAL MEDICATION IS IN THE MANAGERS OFFICE AWAITING PICK 11P FROM S11PPPLY CHAIN.

    Patient problems: Awareness During Anesthesia

    MAUDE report 10617134 ↗
  • MalfunctionAug 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE EXPERIENCED INEFFECTIVE ANESTHESIA -FAILED TO WORK. PRODUCT DEFECT OCCURRED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405672, BATCH NO: 0001346903 , 0001346885 . I HAVE JUST BEEN INFORMED FROM ONE OF OUR FACILITIES THAT THE BUPIVACAINE IN OUR BD ANESTHESIA TRAY (PART NUMBER 405672) DOES NOT WORK FOR NUMBING A PATIENT. THEY TRIED 2 TRAYS AND NEITHER WORKED. THE LOT NUMBERS ARE 0001346903 (0 KITS IN THE ISC, BUT WE WILL BE RECEIVING SOME BACK FROM THE FACILITY) AND 001346885 (CURRENTLY 104 KITS ON HAND IN THE ISC).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10377102 ↗
  • MalfunctionJul 3, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT THE TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE BUPIVACAINE ANESTHESIA WAS INEFFECTIVE DURING USE, AS THE PATIENT "DID NOT GET NUMB AT ALL". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLACED SPINAL WITH NO INDICATION OF MALPLACEMENT. THERE WAS NO EFFECT FROM BUPIVACAINE. PATIENT DID NOT GET NUMB AT ALL. WE HAD TO PLACE ANOTHER SPINAL.".

    Patient problems: Inadequate Pain Relief

    MAUDE report 10228575 ↗
  • MalfunctionDec 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT 3 TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE EXPERIENCED INEFFECTIVE ANESTHESIA -FAILED TO WORK DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405672 BATCH NO. UNKNOWN A FEW PHYSICIANS HAVE HAD ISSUES WITH THE INEFFECTIVE ANESTHESIA. LOT NUMBER IS CURRENTLY UNAVAILABLE PT IDENTIFIERS: NOT AVAILABLE (B)(6) 2019: 3 INCIDENTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9498022 ↗
  • MalfunctionDec 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT THE ANESTHESIA WAS INEFFECTIVE WITH A BD TRAY SPN WHIT 25G3.5 L/B-D/E BLUE DRAPE. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). IT WAS REPORTED THAT THE ANESTHESIA WAS INEFFECTIVE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9496737 ↗
  • MalfunctionOct 2, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT A DRUG POTENCY ISSUE OCCURRED WITH A TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS BROUGHT TO MY ATTENTION THAT ANESTHESIA IS HAVING TROUBLE WITH THE BUPIVACAINE NOT WORKING IN THE SPINAL TRAYS REF: 405672, LOT # 001273494, EXP: 2020-09-30. THEY HAVE BEEN PULLING BUPIVACAINE FROM THE PYXIS SINCE THEY HAVE HAD SO MANY FAILED SPINALS FROM THIS LOT."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9145020 ↗
  • MalfunctionSep 3, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    MATERIAL NO. 405672 BATCH NO. 0001276651. IT WAS REPORTED THAT DURING USE OF THE TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE THE DRUG IS INEFFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS REPORTING THAT THE DRUG WAS NOT WORKING AT ALL ON A PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8956074 ↗
  • InjuryJun 28, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    IT WAS REPORTED THAT TREATMENT FAILURE OCCURRED DURING USE WITH TRAYS SPN WHIT25G3.5 L/B-D/E BLUE DRAPE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT IT TOOK 20 MINUTES FOR THE PATIENT TO BECOME NUMB. PER CUSTOMER EMAIL: GOOD MORNING, WE CURRENTLY USE LAWSON 659015 SPINAL TRAY. SURGERY REPORTED TO US THEY ARE HAVING PROBLEM WITH LOT NUMBER 0001271310. THEY TRIED 4 OF THIS LOT NUMBER ON A PATIENT, IT TOOK OVER 20 MINUTES FOR THE PATIENT TO BECOME NUMB. THEY WILL NOT USE THIS LOT NUMBER ANYMORE¿WE CURRENTLY HAVE 17 OF THESE SPINAL TRAYS WITH THIS LOT NUMBER. ANY HELP YOU CAN GIVE US ON THIS ISSUE WOULD BE GREATLY APPRECIATED."

    Patient problems: Therapeutic Response, Decreased

    MAUDE report 8745037 ↗
  • InjuryMay 14, 2019Defective Device

    IT WAS REPORTED THAT CHANGE IN TREATMENT OCCURRED WITH A TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE BUPIVACAINE DID NOT WORK AND THE PATIENTS HAD TO BE CONVERTED TO GENERAL ANESTHESIA. FOR PATIENT (B)(6). PER EMAIL: A PATIENT WAS TO UNDERGO SPINAL ANESTHESIA AS PRIMARY ANESTHESIA, BUT WAS STILL ABLE TO MOVE THEIR LEG. STAFF HAD TO CONVERT TO GENERAL ANESTHESIA. SIMILAR RESULTS WITH MULTIPLE CASES ON THE SAME DAY.".

    Patient problems: No Code Available

    MAUDE report 8608222 ↗
  • InjuryMay 10, 2019Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT THERE WERE 3 (2 WITH AN UNKNOWN LOT AND 1 WITH LOT # 0001275590) OCCURRENCES WHERE ANESTHESIA GIVEN WAS INEFFECTIVE AND HAD TO CHANGE TO GENERAL ANESTHESIA WITH A BD TRAY SPN¿ WHIT25G3.5 L/B-D/E BLUE DRAPE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE BUPIVACAINE DID NOT WORK AND THE PATIENTS HAD TO BE CONVERTED TO GENERAL ANESTHESIA. PER EMAIL: A PATIENT WAS TO UNDERGO SPINAL ANESTHESIA AS PRIMARY ANESTHESIA, BUT WAS STILL ABLE TO MOVE THEIR LEG. STAFF HAD TO CONVERT TO GENERAL ANESTHESIA. SIMILAR RESULTS WITH MULTIPLE CASES ON THE SAME DAY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8601442 ↗
  • InjuryMay 9, 2019Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT BD¿ WHITACRE SPINAL ANESTHESIA TRAY WAS USED WITH BUPIVACAINE AND IT DID NOT WORK. THE PATIENT'S COURSE OF TREATMENT HAD TO BE CHANGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405672, BATCH: UNKNOWN. IT WAS REPORTED THAT THE BUPIVACAINE DID NOT WORK AND THE PATIENTS HAD TO BE CONVERTED TO GENERAL ANESTHESIA. FOR PATIENT (B)(6). A PATIENT WAS TO UNDERGO SPINAL ANESTHESIA AS PRIMARY ANESTHESIA, BUT WAS STILL ABLE TO MOVE THEIR LEG. STAFF HAD TO CONVERT TO GENERAL ANESTHESIA. SIMILAR RESULTS WITH MULTIPLE CASES ON THE SAME DAY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8596663 ↗
  • InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE CAUSED A CHANGE IN TREATMENT/SERIOUS INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405672 BATCH: UNKNOWN. FOR PATIENT 3/5. PER EMAIL: A PATIENT WAS TO UNDERGO SPINAL ANESTHESIA AS PRIMARY ANESTHESIA, BUT WAS STILL ABLE TO MOVE THEIR LEG. STAFF HAD TO CONVERT TO GENERAL ANESTHESIA. SIMILAR RESULTS WITH MULTIPLE CASES ON THE SAME DAY.

    Patient problems: Therapeutic Effects, Unexpected

    MAUDE report 8595238 ↗
  • InjuryMay 3, 2019Defective Component

    IT WAS REPORTED THAT DURING USE OF THE TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE THE BUPIVACAINE DID NOT WORK AND THE PATIENTS HAD TO BE CONVERTED TO GENERAL ANESTHESIA. MATERIAL NO.: 405672. BATCH: UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR PATIENT 0760 (5/5) PER EMAIL: A PATIENT WAS TO UNDERGO SPINAL ANESTHESIA AS PRIMARY ANESTHESIA, BUT WAS STILL ABLE TO MOVE THEIR LEG. STAFF HAD TO CONVERT TO GENERAL ANESTHESIA. SIMILAR RESULTS WITH MULTIPLE CASES ON THE SAME DAY.

    Patient problems: Therapeutic Effects, Unexpected

    MAUDE report 8579342 ↗
  • InjuryApr 12, 2019Defective Device

    IT WAS REPORTED THAT 2 TRAYS SPN WHIT25G3.5 L/B-D/E BLUE DRAPE FROM LOT # 0001275539, AND 2 TRAYS SPN WHIT25G3.5 L/B-D/E BLUE DRAPE FROM LOT # 0001269741 WERE INEFFECTIVE AT RELIEVING PAIN, WITH THE PATIENT RETAINING FEELING IN THE LEG AND ABLE TO LIFT IT AFTER ANESTHESIA WAS ADMINISTERED. HIGHER BLOOD PRESSURE IN THE PATIENT WAS ALSO REPORTED DURING THE EVENT, AND ADDITIONAL ANESTHESIA AND AFTER-SURGERY PAIN MEDICATION HAD TO BE GIVEN AS A RESULT. THIS COMPLAINT WAS CREATED TO CAPTURE 1 OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "4 TRAYS NOT GIVE PATIENTS PAIN RELIEF. 1 CASE THEY WERE STILL HAVING FEELING AND COULD LIFT THEIR LEG UP. 1 CASE RATED PAIN 4 OUT OF 10 IN RECOVERY. HIGHER BLOOD PRESSURES DURING EACH OF THE CASES. WHICH THEN IN TURNS THEM RECEIVING MORE ANESTHESIA AND PAIN MEDS AFTER SURGERY."

    Patient problems: High Blood Pressure/ Hypertension; Pain

    MAUDE report 8510224 ↗
  • InjuryMar 16, 2019Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT DURING THE C-SECTION, TWO BD¿ TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE DID NOT SET UP PROMPTLY, WHICH MADE PATIENT STILL HAVE THE SENSATION BELOW SPINAL INJECTION, RESULTED IN THE USE OF GENERAL ANESTHESIA FOR THIS PATIENT INSTEAD OF LOCALIZED ANESTHESIA. THIS MADE THE BABY WAS EXPOSED UNNECESSARILY TO GENERAL ANESTHESIA AGENTS. POST THE SURGERY, THE PATIENT HAD ADEQUATE PAIN RELIEF AND SIDE EFFECTS SUCH AS ITCHING FROM THE DURAMORPH, WHICH WAS INJECTED INTO THE SAME SITE. ACCORDING TO THE CUSTOMER, BESIDE THIS EVENT FOR THIS PATIENT, THERE HAVE BEEN MULTIPLE EVENTS HAPPENED.

    Patient problems: Inadequate Pain Relief

    MAUDE report 8426823 ↗
  • InjuryDec 21, 2018Defective Device

    IT WAS REPORTED THAT THE "BUPIVACAINE" IN THE BD¿ WHITACRE SPINAL ANESTHESIA TRAY "WAS INEFFECTIVE", AND THERE WERE ¿SOME DELAYS IN THE PROCEDURE¿ AS A RESULT. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR PATIENT HARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8190533 ↗

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