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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD SHIELDED IV CATHETER 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 01/25/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter e-mail: (b)(6). (b)(4). Investigation summary: there was no sample or photo of the defect available to bd for evaluation. A photo was provided of the label but not of the product defect. Therefore, bd was unable to perform a thorough investigation to verify the reported issue. Since, an investigation could not be performed bd was unable to determine a possible root cause. The manufacturing facility has been notified of this incident and the findings. A review of the device history record was performed and no quality issues were found during production. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the safety mechanism on the bd insyte¿ autoguard¿ shielded iv catheter failed to activate and the employee suffered a dirty needle stick on the left hand as a result. Blood tests were drawn, and neither the patient nor employee were positive for infectious diseases. The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021 one of our employees suffered an accident at work with the 22g x 1. 00 batch catheter: lot0216319. According to the worker, the safety device did not activate when pressing the button. " was there any harm to the patient / healthcare professional? (detail) (the employee received all support regarding the accident if he was referred to the protocol for assistance to the occupational and sexual biological risk (parbos) and because he had a source patient, both tests (patient and employee) were negative for any type of infected disease contagious. The patient had no damage). Was there a need for medical and / or surgical intervention due to what happened (imaging exams, surgery, medication administration, etc. )? (detail) (no!). Was there blood or chemotherapy exposure to mucous membranes or skin? (detail) (yes! by the employee, as he pierced the 1st finger of his left hand). What medication was being administered? (an antibiotic was going to be administered, but the accident occurred before the medication was administered to the patient).
 
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Brand NameBD INSYTE AUTOGUARD SHIELDED IV CATHETER
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 Key11361141
MDR Text Key233074562
Report Number9610048-2021-00023
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
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
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 Number0216319
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 Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2020
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: 02/22/2021 Patient Sequence Number: 1
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