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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ CATHETER I.V. INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ CATHETER I.V. INTRAVASCULAR CATHETER Back to Search Results
Model Number 381823
Device Problem Retraction Problem (1536)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 09/08/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported bd insyte¿ autoguard¿ catheter i. V. Was difficult to activate. The following information was provided by the initial reporter, translated from (b)(6): "safety device of insyte n°22 showing resistance to being activated, piercing the employee's finger. ".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ CATHETER I.V.
Type of DeviceINTRAVASCULAR CATHETER
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12583951
MDR Text Key274969171
Report Number9610048-2021-00134
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381823
Device Catalogue Number38182314
Device Lot Number0216345
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2020
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: 10/06/2021 Patient Sequence Number: 1
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