MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERITONEAL DRAINAGE CATHETER INSERTION TRAY 15.5 FR ASPIRA; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number PRODUCT CODE: 4992209

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2022

Event Type  malfunction  

Event Description

Felt cuff on the peritoneal drainage catheter insertion tray catheter broke off at the skin when it was being tunneled.Surgeon claims this is not the first occurrence.Fda safety report id # (b)(4).

• Brand Name: PERITONEAL DRAINAGE CATHETER INSERTION TRAY 15.5 FR ASPIRA
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 14043231
• MDR Text Key: 288874783
• Report Number: MW5108812
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2022

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 Operator: Health Professional
• Device Model Number: PRODUCT CODE: 4992209
• Device Lot Number: I2291830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White