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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE AUTOGUARD BL 22GA X 1.0IN CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE AUTOGUARD BL 22GA X 1.0IN CATHETER Back to Search Results
Model Number 381823
Device Problem Retraction Problem (1536)
Patient Problem Needle Stick/Puncture (2462)
Event Date 01/29/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter zip: (b)(6). 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 insyte autoguard bl 22ga x 1. 0in needle would not retract. This occurred on 2 occasions. The following information was provided by the initial reporter: customer reported an accident at work with a collaborator in the endoscopy sector, where the same was punctured with the bd catheter, as it locked the safety device when activated, not retracting the needle for the protection camera. Additional information: customer informed that there was no medical intervention, however, the employee is using prophylactic medication. The sample is available (contaminated).
 
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Brand NameINSYTE AUTOGUARD BL 22GA X 1.0IN
Type of DeviceCATHETER
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 Key11408208
MDR Text Key234616506
Report Number9610048-2021-00029
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381823
Device Catalogue Number38182314
Device Lot Number0216348
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 Received04/08/2021
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: 03/03/2021 Patient Sequence Number: 1
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