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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 SYRINGE

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CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA SYRINGE Back to Search Results
Catalog Number 400866
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Awareness during Anaesthesia (1707); Pain (1994)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Date of birth: unknown. The patient¿s age was used to determine a placeholder date.
 
Event Description
It was reported that 25gx3. 5in whit 5ml glaspak bupi clear had ineffective anesthesia. The following information was provided by the initial reporter: "it was reported that the spinal anesthesia administered was ineffecive. "verbatim - failed spinal - positive cerebrospinal fluid (csf) aspiration, 1. 8ml 0. 75% marcaine, 200 mcg duramorph, 10 mcg fentanyl given after positive csf aspiration. After medications were injected, again positive aspiration was noted as well. Spinal not adequate for surgery, general anesthesia needed. Note from the operative report: "the patient was taken to the operating room where spinal anesthesia was administered, but was not adequate to control the pain. She had to be converted to general". There were no complications noted".
 
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Brand Name25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
Type of DeviceANESTHESIA SYRINGE
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10690607
MDR Text Key246422655
Report Number1625685-2020-00093
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
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
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 Received02/19/2021
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: 10/16/2020 Patient Sequence Number: 1
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