MAUDE Adverse Event Report: INNOVATIVE MEDICAL TECHNOLOGIES, INC PREVENT G; SAFETY BLOOD COLLECTION SET

Model Number 16-BC2134

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Customer filed fda med watch report back in dec 2021.Mckesson qa was officially notified on sept 1st 2022.I have been trying to get a production accoutn since oct 2022.Received production account 3/8/23.Safety did not properly engage after it clicked, resulting to needle stick.

• Brand Name: PREVENT G
• Type of Device: SAFETY BLOOD COLLECTION SET
• Manufacturer (Section D): INNOVATIVE MEDICAL TECHNOLOGIES, INC; 14315 c circle; omaha NE 68144
• Manufacturer (Section G): GUANGZOU IMPROVE MEDICAL INSTRUMENTS CO., LTD; no. 102, kaiyuan ave, science; guangzhou etdz; guangzhou, cn-44 51053 0; CH 510530
• Manufacturer Contact: brad brown ; 14315 c circle; omaha, NE 68144 ; 9135150917
• MDR Report Key: 16522288
• MDR Text Key: 311560592
• Report Number: 3001451226-2023-00001
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 20612479206070
• UDI-Public: 20612479206070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123987
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-BC2134
• Device Catalogue Number: 16-BC2134
• Device Lot Number: 210705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• 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