MAUDE Adverse Event Report: GENICON GENICON; POLY POUCH (PORTS CODE)

Model Number 210-005-152

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Capa (b)(4) has been issued to operations to investigate the failure and ensure proper containment and corrective actions.

Event Description

A unit of product, 210-005-152 (i9525-a) was found to not be sealed by the manufacturer thus the sterile barrier was not in tact when it reached the customer.

• Brand Name: GENICON
• Type of Device: POLY POUCH (PORTS CODE)
• Manufacturer (Section D): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer (Section G): GENICON; 6869 stapoint court; suite 114; winter park FL 32792
• Manufacturer Contact: katlyn kachman ; 6869 stapoint court; suite 114; winter park, FL 32792 ; 4076574851
• MDR Report Key: 8448736
• MDR Text Key: 139989328
• Report Number: 3002590791-2019-00001
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 00877972005452
• UDI-Public: 00877972005452
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K982472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/06/2023
• Device Model Number: 210-005-152
• Device Catalogue Number: 210-005-152
• Device Lot Number: I9525-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• 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): Other