MAUDE Adverse Event Report: CONMED CORPORATION CORE DYNAMICS; CATHETER, PERITONEAL

Model Number CD8185

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

Tip of the core trumpet suction irrigator was broken where it attached to the irrigation bag.

Event Description

Tip of the core trumpet suction irrigator was broken where it attached to the irrigation bag.

• Brand Name: CORE DYNAMICS
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): CONMED CORPORATION; 6455 s yosemite st ste 800; greenwood village CO 80111
• MDR Report Key: 13975545
• MDR Text Key: 288366995
• Report Number: 13975545
• Device Sequence Number: 1
• Product Code: GBW
• 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,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CD8185
• Device Catalogue Number: CD8185
• Device Lot Number: 202109205
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Sex: Female
• Patient Weight: 96 KG