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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD DURASAFE¿ COMBINED ANESTHESIA KIT ANETHESIA COMBINED SPINAL & EPIDURAL KIT

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD DURASAFE¿ COMBINED ANESTHESIA KIT ANETHESIA COMBINED SPINAL & EPIDURAL KIT Back to Search Results
Catalog Number 401386
Device Problem Material Integrity Problem (2978)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/02/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Initial reporter phone#: (b)(6). 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.
 
Event Description
It was reported that there was an accidental puncture while using the bd durasafe¿ combined anesthesia kit. The following information was provided by the initial reporter: accidental puncture of the dura mater - 3 occurrences in one week. The anesthesiology team is accustomed to using the braun epidural kit - as it is an ultra fine sensitivity, the epidural puncture, the change of the mark implies a great modification of the sensitivity in expiration of the plans the anesthesiology team released exceeded by the needle.
 
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Brand NameBD DURASAFE¿ COMBINED ANESTHESIA KIT
Type of DeviceANETHESIA COMBINED SPINAL & EPIDURAL KIT
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8620311
MDR Text Key145401481
Report Number9610048-2019-00181
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number401386
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
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: 05/17/2019 Patient Sequence Number: 1
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