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

Model Number NMT8046

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

Bedside rn (registered nurse) reassessed pal and notice the line was split nearest the t connector.The hummi t connector was replaced, flushed, aspirated, and re-secured.

• Brand Name: HUMMI MICRO DRAW T-CONNECTOR
• Type of Device: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• Manufacturer (Section D): KENTEC MEDICAL, INC.
• MDR Report Key: 18960202
• MDR Text Key: 338495924
• Report Number: MW5153056
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NMT8046
• Device Lot Number: 583009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 8 DA
• Patient Sex: Female