MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC ORIGEN REINFORCED DUAL LUMEN CATHETER; VV ECMO CATHETER

Model Number VV13F

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturer was able to verify the observation of the 5cm print mark being off my one centimeter and appearing at 4cm from the tip.Relying on just the print marking to position the catheter would leave the catheter under-inserted, meaning that inserting to the 5cm mark would only place the catheter 4cm deep.The instructions for use require the user to "verify position of the catheter in the right atrium using x-ray or ultrasound." the printing error was a result of the drawing being incorrectly dimensioned andn the error was not noticed when the drawing was approved.The drawing has been corrected following notice of this incident/malfunction.

Event Description

The print number on the catheter is off by 1cm.

• Brand Name: ORIGEN REINFORCED DUAL LUMEN CATHETER
• Type of Device: VV ECMO CATHETER
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC; 7000 burleson rd.; bldg. d; austin TX 78744
• Manufacturer (Section G): ORIGEN BIOMEDICAL, INC; 7000 burleson rd.; bldg. d; austin TX 78744
• Manufacturer Contact: kiersten soderman ; 7000 burleson rd.; bldg. d; austin, TX 78744 ; 5126157606
• MDR Report Key: 8472107
• MDR Text Key: 140877079
• Report Number: 1646848-2019-00008
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: VV13F
• Device Lot Number: R19506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0179-2019
• Patient Sequence Number: 1