• 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 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 ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 406704
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 4 bd¿ spinal anesthesia trays had holes in their sterile packaging, compromising their sterility. The following information was provided by the initial reporter: "it was reported that there are holes in the sterile covering. " "we are experiencing another problem with the spinal tray. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD¿ SPINAL ANESTHESIA TRAY
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12807069
MDR Text Key283248471
Report Number1625685-2021-00090
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 01/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model Number406704
Device Catalogue Number406704
Device Lot Number0001419161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-