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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 TRAY

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CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA TRAY Back to Search Results
Catalog Number 400866
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that an 25gx3. 5in whit 5ml glaspak bupi clear contained anesthesia that was ineffective. The following information was provided by the initial reporter: "it was reported the bupivacaine was ineffective in this lot. ".
 
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Brand Name25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
Type of DeviceANESTHESIA TRAY
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10070806
MDR Text Key193618296
Report Number1625685-2020-00046
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
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
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 Number0001343142
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/19/2020 Patient Sequence Number: 1
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