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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA KIT

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BECTON DICKINSON 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR ANESTHESIA KIT Back to Search Results
Catalog Number 400866
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Inadequate Pain Relief (2388)
Event Date 04/28/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 25gx3. 5in whit 5ml glaspak bupi clear was used and the anesthesia was ineffective. This was discovered during use. 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 KIT
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10090136
MDR Text Key198296149
Report Number1625685-2020-00047
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 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
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 NumberUNKNOWN
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? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/26/2020 Patient Sequence Number: 1
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