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

Model Number	16-BC2134
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 3001451226-2023-00001
• Device Sequence Number: 15081773
• Product Code: JKA
• UDI-Device Identifier: 20612479206070
• UDI-Public: 20612479206070
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 16-BC2134
• Device Catalogue Number: 16-BC2134
• Device Lot Number: 210705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown