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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANESTHESIA TRAY BASIC SPINAL ANESTHESIA CONDUCTION KIT

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANESTHESIA TRAY BASIC SPINAL ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 401383
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the shipping box of anesthesia trays basic spinal was found "dirty/wet". The following information was provided by the initial reporter, translated from (b)(4) to english: "it was found in customer's warehouse the package dirty/wet, they believe it has come with the issue because no other product has been found with the same issue. ".
 
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Brand NameANESTHESIA TRAY BASIC SPINAL
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key10860818
MDR Text Key217068368
Report Number9610048-2020-00156
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2021
Device Catalogue Number401383
Device Lot Number9158555
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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