MAUDE Adverse Event Report: SOPHYSA KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH

Model Number FVPC4

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 07/07/2020

Event Type  malfunction  

Event Description

The hospital informed us about a catheter breakage.No information about the concerned product or consequences on patient were communicated by the hospital even after several requests.

• Brand Name: KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH
• Type of Device: KUBALA EXTERNAL DRAINAGE CATHETER 35CM LENGTH
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer Contact: viviane payrou ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 10481139
• MDR Text Key: 205288697
• Report Number: 3001587388-2020-20426
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K853365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FVPC4
• Device Catalogue Number: FVPC4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1