MAUDE Adverse Event Report: GENICON, INC. GENICON 2EZEE SPECIMEN RETRIEVAL BAG; SPECIMEN RETREIVAL BAG

Model Number 550-000-200

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

This reportable event was identified during a review of complaint files between (b)(6) 2017 through (b)(6) 2019.This report is for the 2nd device listed in the complaint.

Event Description

From initial report: (b)(6) 2019- during trial of new formulary specimen retrieval bag from genicon, the bag tore and failed 3 out of 5 attempts to use it.The rep was present for the trial and available for questions and instructions on use.Revision 1, from product experience report (per) 00654: during trial of new formulary specimen retrieval bag from genicon, the bag tore and failed 3 out of 5 attempts to use it.The bag popped at the bottom of the bag during attempted retrieval through the defect.

• Brand Name: GENICON 2EZEE SPECIMEN RETRIEVAL BAG
• Type of Device: SPECIMEN RETREIVAL BAG
• Manufacturer (Section D): GENICON, INC.; 6869 stapoint ct.; suite 114; winter park, fl
• Manufacturer (Section G): GENICON, INC.; 6869 stapoint court; suite 114; winter park, fl
• Manufacturer Contact: marianne feyas ; 6869 stapoint court; suite 114; winter park, fl ; 6574851401
• MDR Report Key: 10385376
• MDR Text Key: 205131144
• Report Number: 3002590791-2020-00091
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00877972007289
• UDI-Public: (01)00877972007289(10)J0350-A(11)190423(17)201022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2020
• Device Model Number: 550-000-200
• Device Lot Number: J0350-A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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