MAUDE Adverse Event Report: LANGSTON V2; DUAL LUMEN CATHETER

Model Number	5540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.The manufacturing lot was reviewed and no nonconformances related to this issue was noted, therefore, supporting the device met material, assembly and performance specifications.The account sent an image of the langston catheter.Based off the image, the strain relief had a longitudinal tear.No other damage could be noted.No patient injury or harm was reported.
Event or Problem Description
As reported: lumen above the device hub blew out while in use on patient.Additional information received 17aug2020: the patient is doing well.The device was disposed of after the reporting.It did not happen during a power injection.The lumen did not require retrieval or use of a snare.No patient injury reported.

• Brand Name: LANGSTON V2
• Common Device Name: DUAL LUMEN CATHETER
• MDR Report Key: 10448564
• Report Number: 2134812-2020-00049
• Device Sequence Number: 3558887
• Product Code: DQO
• UDI-Device Identifier: 30841156100517
• UDI-Public: (01)30841156100517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 5540
• Device Lot Number: 650873
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 01/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0110-2021-Z-0113-2021
• Patient Sequence Number: 1