MAUDE Adverse Event Report: HUMMINGBIRD MED DEVICES INC HUMMI MICRO DRAW TRANSFER DEVICE; SYSTEM, BLOOD COLLECTION

Catalog Number ABG-HM-1

Device Problems Crack (1135); Leak/Splash (1354); Defective Device (2588)

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

Event Date 12/01/2019

Event Type  malfunction  

Event Description

Hummi micro-draw blood transfer device used to obtain blood gas reported to be defective with leak/crack.

• Brand Name: HUMMI MICRO DRAW TRANSFER DEVICE
• Type of Device: SYSTEM, BLOOD COLLECTION
• Manufacturer (Section D): HUMMINGBIRD MED DEVICES INC; 1283 elger bay road ste d; camano island WA 98282
• MDR Report Key: 9745208
• MDR Text Key: 180583039
• Report Number: 9745208
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ABG-HM-1
• Device Lot Number: 19129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Date Report to Manufacturer: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 DA
• Patient Weight: 1