MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERITONEAL DIALYSIS CATHETER

Catalog Number CF-5560

Device Problems Material Rupture (1546); Material Separation (1562)

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

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

Account alleges that post pd catheter placement, the catheter was found broken at the connector on the distal side.The catheter was shortened and reconnected by the physician.Approximately one month later, the catheter tubing broke again on the proximal side.The entire device was removed and replaced resulting in no additional consequences to the patient.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed.The root cause is attributed to user technique.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: PERITONEAL DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 9130585
• MDR Text Key: 163048453
• Report Number: 1721504-2019-00076
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CF-5560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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