MAUDE Adverse Event Report: HUMMINGBIRD MEDICAL DEVICES, INC HUMMI; BLOOD DRAW TRANSFER DEVICE

Model Number ABG-HM-1

Device Problem Material Separation (1562)

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

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

Data indicates the y-connector was potentially molded undersized creating a smaller outside diameter of y leg as designed to fit into the corresponding hub.This went undetected by supplier.This created a loose fit not having a sufficiently strong enough bond.

Event Description

A cannula hub (yellow in color) is bonded to a y-connector of the device.This bond joint was discovered to be insufficient (came apart) by the sale rep during routine visit at the hospital while handling the device.The experience of the sales rep prompted him to raise the question of the manufacturer since this had not preciously been experienced.This was a new e.

• Brand Name: HUMMI
• Type of Device: BLOOD DRAW TRANSFER DEVICE
• Manufacturer (Section D): HUMMINGBIRD MEDICAL DEVICES, INC; lake forest CA 92630
• Manufacturer (Section G): YANTAI KAIBO AUTOMATION TECHNOLOGIES; taiwan industrial park, muping; yantai city, shandong province 26411 4; CH 264114
• Manufacturer Contact: jorge haider ; 20371 ste6a lake forrest drive; lake forest, CA 92630 ; 9492156453
• MDR Report Key: 5182143
• MDR Text Key: 30042243
• Report Number: 3009382876-2015-00002
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/01/2020
• Device Model Number: ABG-HM-1
• Device Lot Number: 15180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 29091501
• Patient Sequence Number: 1