MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 20GA X 1.16IN CATHETER

Catalog Number 38831414

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Phlebitis (2004); Insufficient Information (4580)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.

Event Description

It was reported that insyte 20ga x 1. 16in. The following information was provided by the initial reporter: the patient entered the clinic for an outpatient colonoscopy procedure on (b)(6) and an iag 20g was inserted into the back of the right hand, no more than 2 hours elapsed, since it was a short ambulatory procedure. They removed the immobilization adhesives from the peripheral catheter iag 20g on the back of the right hand and then the patient arrives consulting because the vein is inflamed, they performed ultrasound and report that a tubular image of hyperechoic walls with 30mm length is observed, they reconfirm with doppler and refer endoluminal foreign body. Presence of the catheter within the patient's vein, pending assessment by a vascular surgeon on thursday, (b)(6). Additional information received on 07/30/2021: there is no batch information, the catheter did not break, the propofol drug was being used, the catheter was not occluded at any time, we checked the patency of the catheter with saline solution. The catheter was discarded. There was no need to remove any catheter fragments from the patient.

• Brand Name: INSYTE 20GA X 1.16IN
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 12310716
• MDR Text Key: 266147717
• Report Number: 9610048-2021-00113
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38831414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 08/11/2021 Patient Sequence Number: 1