MAUDE Adverse Event Report: TITUS MEDICAL TITUS MEDICAL HSG CATHETER 06-105F, 5FR; HSG CATHETER, 5FR

Model Number HSG CATHETER, 5FR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2017

Event Type  malfunction  

Event Description

Pt called the physician to report a retained foreign object.The pt stated something was left inside of her after a saline sonogram was performed, and that it had come out of her vagina later the same day.A titus medical hsg catheter was used during a hysterosalpingography.Member described item as a small, while plastic cylindrical tube approx 1" long.Pt brought the item in and the healthcare professional determined it to be a plastic tip of the sonohysterography catheter.

• Brand Name: TITUS MEDICAL HSG CATHETER 06-105F, 5FR
• Type of Device: HSG CATHETER, 5FR
• Manufacturer (Section D): TITUS MEDICAL
• MDR Report Key: 6325783
• MDR Text Key: 67374615
• Report Number: MW5067840
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2017

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 Model Number: HSG CATHETER, 5FR
• Device Lot Number: 20160905A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR