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

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).

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR 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 Key: 11361141
• MDR Text Key: 233074562
• Report Number: 9610048-2021-00023
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 381823
• Device Catalogue Number: 38182314
• Device Lot Number: 0216319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention