MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY MYOSURE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number 383531

Device Problem Improper Flow or Infusion (2954)

Patient Problem Laceration(s) (1946)

Event Date 09/26/2022

Event Type  malfunction  

Event Description

During a surgical hysteroscopy the myosure was infiltrating the saline very rapidly.The surgeon paused the procedure, and the rep was called for guidance.After speaking to him the doctor stopped the procedure as the fundus was perforated.The surgeon used ultrasound at the end of the procedure to verify if excess fluid was in the patient.

• Brand Name: MYOSURE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 15787595
• MDR Text Key: 303546152
• Report Number: 15787595
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022

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 Catalogue Number: 383531
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1