MAUDE Adverse Event Report: COOK, INC. NOVY; CATHETERS, SALPINGOGRAPHY

Model Number J-NCS-503500

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 09/16/2014

Event Type  malfunction  

Event Description

During tubal cannulation procedure, it was noted that the distal end of the novy cannula broke off of the cannula device.This end of the device does not go into the patient.All pieces were recovered.Another device was procured and used as needed.

• Brand Name: NOVY
• Type of Device: CATHETERS, SALPINGOGRAPHY
• Manufacturer (Section D): COOK, INC.; 750 daniel way; bloomington IN 47404
• MDR Report Key: 4143286
• MDR Text Key: 4928012
• Report Number: 4143286
• Device Sequence Number: 1
• Product Code: MOV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/17/2014

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: Physician
• Device Model Number: J-NCS-503500
• Device Catalogue Number: G26822
• Device Lot Number: U2207204
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2014
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 125