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

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).

• Brand Name: INSYTE AUTOGUARD BL 22GA X 1.0IN
• Type of Device: 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: 11408208
• MDR Text Key: 234616506
• Report Number: 9610048-2021-00029
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381823
• Device Catalogue Number: 38182314
• Device Lot Number: 0216348
• 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 Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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