• 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 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA 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 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA KIT Back to Search Results
Catalog Number 400866
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
Date of birth: unknown. Date of event: unknown. The date received by manufacturer has been used for this field. The initial reporter also notified the fda on 3 august, 2020. Medwatch report # (b)(4) report source other: medwatch report. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that 25gx3. 5in whit 5ml glaspak bupi clear anesthesia was ineffective. This was discovered during use. The following information was provided by the initial reporter: material no: 400866 batch no: 0001311129. It was reported that the anesthesia was ineffective which required the procedure to be completed using general anesthesia. Event description per email states: 0630. Scheduled repeat cesarean section. Easy spinal, 1st attempt by crna. Free flowing cerebrospinal fluid (csf) drops and swirl in syringe ¿ 1. 6ml of kit 0. 75% bupivacaine + 10mcg fentanyl + 200mcg duramorph injected. Foley insertion tolerated, patient able to move legs and differentiate cold, touch, sharp. Lot # of spinal kit ¿ 0001311129. Patient had to have general anesthesia due to failed spinal. Notes from the operative report. ¿the patient was taken to the operating room where spinal anesthesia was performed, seemingly without complication, but was noted to be not effective at this point. Anesthesia determined she would require general anesthesia. General anesthesia was initiated without complication.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
Type of DeviceANESTHESIA KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10590747
MDR Text Key208830063
Report Number1625685-2020-00088
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2021
Device Catalogue Number400866
Device Lot Number0001311129
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2019
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: 09/25/2020 Patient Sequence Number: 1
-
-