MAUDE Adverse Event Report: HUMMINGBIRD MED HUMMI MICRO-DRAW; SYSTEM, BLOOD COLLECTION

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2019

Event Type  malfunction  

Event Description

When uac was accessed with hummi micro draw, air bubbles were noted with drawback.There were drops of blood leaking from the hub of the catheter.The transfer device was removed and patient had a redrawn.

• Brand Name: HUMMI MICRO-DRAW
• Type of Device: SYSTEM, BLOOD COLLECTION
• Manufacturer (Section D): HUMMINGBIRD MED; 1283 elger bay road ste d; camano island WA 98282
• MDR Report Key: 8929901
• MDR Text Key: 155546456
• Report Number: 8929901
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2019
• Date Report to Manufacturer: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 DA