Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD BUPIVACAINE SPINAL TRAY 25G X 3.5; ANESTHESIA CONDUCTION KIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON BD BUPIVACAINE SPINAL TRAY 25G X 3.5; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405671
Device Problem Output Problem (3005)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/20/2022
Event Type  malfunction  
Event Description
Chief of anesthesia shared that they had two failed spinal anesthesia approaches.Access was easily obtained from a patient anatomy standpoint.Correct placement was confirmed by two providers.They injected the bupivacaine 0.75% with dextrose 8.25% from the spinal anesthesia tray by vendor bd(becton dickinson) product #405671, lot #0001493304 and the patient continued to have full sensation.A new tray was obtained, same medication injected from the new tray and full sensation continued.After raising a concern it was confirmed that another location experienced the same issue and had the same lot# on hand.We believe that the bupivacaine 0.75% with dextrose 8.25% in this lot is ineffective.We have pulled this specific lot # (about 40 kits) from the system and put a new lot in place without any report issues to date.We are planning to test these kits and send back to the manufacture as they are aware of the situation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD BUPIVACAINE SPINAL TRAY 25G X 3.5
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key16067681
MDR Text Key306408264
Report NumberMW5114049
Device Sequence Number2
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/23/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number405671
Device Catalogue Number405671
Device Lot Number00001493304
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
-
-