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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA KIT

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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 Problems Awareness during Anaesthesia (1707); Pain (1994)
Event Date 07/17/2020
Event Type  malfunction  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. 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)(6).
 
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: 0001345574. It was reported that the failed spinal was converted to general anesthesia. Verbatim: failed spine that converted to general anesthesia. Easy spinal, first attempt with free flow of csf, positive swirl in syringe at beginning, middle and end of injection of 1/8ml of 0. 75% marcaine (from pyxis), 200 mcg of duramorph and 10mcg fentanyl (aoc0091, exp 2020-12). The patient tolerated the c-section until fascia. Foley insertion tolerated, could not feel cold from prep, motor block slow to set up, patient level t6-7 placed in trendelenburg. Patient passed surgeon testing but did not tolerate once they reached the fascial layer. Patient was taken to the operating room where regional anesthesia was maintained and then prepped and drapped in the normal sterile fashion in the left lateral tilt position. Time out was taken and verified x3. At 0949 a pfannensteil incision was made with a scapel, and carried down to the fascia with electrocautery. Due to excessive pain, anesthesia converted to general with the glide scope at 1003. The c-section was carried out with no complications.
 
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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 Key10564353
MDR Text Key208491329
Report Number1625685-2020-00085
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 other,user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number400866
Device Lot Number0001345574
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2020
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: 09/21/2020 Patient Sequence Number: 1
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