MAUDE Adverse Event Report: INNOVATIVE MEDICAL TECHNOLOGIES INNOVATIVE MEDICAL TECHNOLOGIES INC.; PUSH BUTTON BLOOD COLLECTION SET

Catalog Number	16-BC2134
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Could not reproduce problem during testing.
Event or Problem Description
During removal of the butterfly needle, the yellow component, that covers the needle after use, detached unexpectedly, resulting in the needle no longer being covered.

• Brand Name: INNOVATIVE MEDICAL TECHNOLOGIES INC.
• Common Device Name: PUSH BUTTON BLOOD COLLECTION SET
• Manufacturer (Section D): INNOVATIVE MEDICAL TECHNOLOGIES; 16904 rosehill st; overland park KS 66221
• Manufacturer (Section G): INNOVATIVE MEDICAL TECHNOLOGIES; 16904 rosehill st; overland park KS 66221
• Manufacturer Contact: brad brown ; 16904 rosehill st; overland park, KS 66221
• MDR Report Key: 22480364
• Report Number: 3001451226-2025-00004
• Device Sequence Number: 8498925
• Product Code: JKA
• UDI-Device Identifier: 20612479206070
• UDI-Public: 20612479206070
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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 Catalogue Number: 16-BC2134
• Device Lot Number: 241026M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2024
• 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
• Patient Sex: Unknown