MAUDE Adverse Event Report: NULL

Lot Number UNKNOWN

Device Problems Structural Problem (2506); Deformation Due to Compressive Stress (2889)

Patient Problem Fistula (1862)

Event Date 01/01/2020

Event Type  Injury  

Event Description

(1/2 reference (b)(4) for all related complaints).Smj#cfff107.During the use of the product (a tube), brachiocephalic artery fistula occurred in the patient.The customer suspected that something was wrong with the length and the angle of the product.Therefore, they switched it to competitor's ones.The affected item is either 100/860, 100/811, or 100/800.

• Manufacturer (Section G): NULL
• MDR Report Key: 9988194
• MDR Text Key: 188641136
• Report Number: 3012307300-2020-03233
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2020
• 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: N
• Patient Sequence Number: 1