• 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 TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE 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 TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405672
Device Problem Defective Device (2588)
Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994)
Event Date 03/20/2019
Event Type  Injury  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0001275539, medical device expiration date: 2020-09-30, device manufacture date: 2018-12-03. Medical device lot #: 0001269741, medical device expiration date: 2020-06-30, device manufacture date: 2018-10-30. Pma/510(k)#: enforcement discretion. Device evaluated by mfr: 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 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. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8510224
MDR Text Key141941839
Report Number1625685-2019-00021
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405672
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2019
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

Patient Treatment Data
Date Received: 04/12/2019 Patient Sequence Number: 1
-
-