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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 Problem Awareness during Anaesthesia (1707)
Event Date 09/10/2020
Event Type  Injury  
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. Medical device expiration date: unknown. The initial reporter also notified the fda on 31 august, 2020. Medwatch report # 1000870000-2020-8058. 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. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that 25gx3. 5in whit 5ml glaspak bupi clear anesthesia was ineffective. This was discovered after use. The following information was provided by the initial reporter: material no: 400866 batch no: unknown. It was reported that the anesthesia was ineffective. Event description per email states: a patient about to undergo total knew revision, was administered spinal anesthesia prior to the case. However, the spinal failed, and the patient went on to have general regional anesthesia. The operative note indicates "the patient was taken to the operating theater where spinal was performed. She still had some pain and therefore general anesthesia was induced. " the procedure was carried out with no complications. What was the original intended procedure? revision right total knee arthroplasty what problem did the user have: device failed.
 
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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 Key10571320
MDR Text Key208097684
Report Number1625685-2020-00087
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
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400866
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
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: 09/22/2020 Patient Sequence Number: 1
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