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

Catalog Number	16-BC2134
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A definitive root cause could not be confirmed.A review of quality and production documentation did not identify any issues; the retained samples examined showed no nonconformity.This type of failure has occurred rarely over ten years of sales.This failure type could happen during device assembly if the shield isn't completely snapped together.
Event or Problem Description
Safety splits into two halves- the needles pops back out.- unsure if injury or medical attention was needed at this time.

• 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: 25193575
• Report Number: 3001451226-2026-00002
• Device Sequence Number: 10036096
• Product Code: JKA
• UDI-Device Identifier: 20612479206070
• UDI-Public: 20612479206070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 16-BC2134
• Device Lot Number: 250815M
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2025
• 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