• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH L 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
 

CAREFUSION, INC BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH L ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405673
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field. Address information was not able to be obtained, therefore, nj was used as a place holder. Medical device lot #: 405673 was reported, however, this is not a lot # manufactured for the reported catalog #. Medical device expiration date: unknown. Device manufacture date: unknown. Medical device lot #: 072353a was reported, however, this is not a lot # manufactured for the reported catalog #. A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd spinal anesthesia tray 25 gauge 3. 5 inch l the medication was ineffective. This occurred 6 times. There was no report of patient impact. The following information was provided by the initial reporter: it was reported by the consumer several failed spinals.   "we have had several (approx. 5) failed spinals using the bupivicaine out of the bd spinal anesthesia trays, "we have another possible failed spinal from a spinal anesthesia tray used today.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH L
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14242628
MDR Text Key291244017
Report Number1625685-2022-00048
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number405673
Device Catalogue Number405673
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-