MAUDE Adverse Event Report: KENTEC MEDICAL INC. HUMMI MICRO-DRAW; SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL

Catalog Number NMT8046

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

Peripheral arterial line began to spray blood on infant.During inspection - hummi device noticed to be cracked at the joining section of the clear portion of the device.

• Brand Name: HUMMI MICRO-DRAW
• Type of Device: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• Manufacturer (Section D): KENTEC MEDICAL INC.
• MDR Report Key: 18788348
• MDR Text Key: 336473664
• Report Number: MW5152009
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NMT8046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 DA
• Patient Sex: Male