MAUDE Adverse Event Report: ORIGEN BIOMEDICAL ORIGEN REINFORCED DUAL LUMEN ECMO CATHETER; VV13F CATHETER

Model Number VV13F

Device Problems Nonstandard Device (1420); Device Dislodged or Dislocated (2923)

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

Event Date 03/27/2015

Event Type  malfunction  

Event Description

During use on a pt by a hospital employee the clear tube of a vv13f catheter became disconnected from the blue hub.

• Brand Name: ORIGEN REINFORCED DUAL LUMEN ECMO CATHETER
• Type of Device: VV13F CATHETER
• Manufacturer (Section D): ORIGEN BIOMEDICAL; 7000 burleson rd; bldg d; austin TX 78744
• Manufacturer Contact: bernie silvers ; 7000 burleson rd; bldg d; austin, TX 78744 ; 5124747278
• MDR Report Key: 4672432
• MDR Text Key: 16850774
• Report Number: 1646848-2015-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: VV13F
• Device Catalogue Number: VV13F
• Device Lot Number: N18549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention