MAUDE Adverse Event Report: HUMMINGBIRD MED DEVICES, INC.; BLOOD DRAW TRANSFER DEVICE

Model Number ABG-HM-1

Device Problem Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Hummingbird med received a product complaint from baxter healthcare involving their interlink t-connector when used with a hummi micro draw blood transfer device.The customer tried to insert the hummi's blunt cannula in the middle of the interlink t-connector port.The t-connector's port caved-in and the patient started bleeding out.The hospital did not know how much blood was lost from the patient but the patient did need a blood transfusion.Hummingbird med has informed the hospital of improper use of the hummi and to use it only with an approved micro-t connector validated for use with the hummi.

Event Description

Hummingbird med received a product complaint from baxter healthcare involving their interlink t-connector when used with a hummingbird med hummi micro draw blood transfer device.The customer tried to insert the hummi blunt cannula in the middle of the interlink t-connector port.The t-connector port caved-in and patient started bleeding out.The hospital did not know how much blood was lost from patient but the patient did need a blood transfusion.

• Type of Device: BLOOD DRAW TRANSFER DEVICE
• Manufacturer (Section D): HUMMINGBIRD MED DEVICES, INC.; 20371 lake forest blvd; lake forest CA 92630
• Manufacturer Contact: jorge haider ; 20371 lake forest blvd; lake forest, CA 92630 ; 7605856525
• MDR Report Key: 6545515
• MDR Text Key: 74472190
• Report Number: 3009382876-2017-00001
• Device Sequence Number: 1
• Product Code: KST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ABG-HM-1
• Device Catalogue Number: ABG-HM-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1908-2016
• Patient Sequence Number: 1