MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. FLEX-NECK ARC PERITONEAL DIALYSIS CATH; CATHETER, PERITONEAL, LONG-TERM

Catalog Number CF-5260

Device Problem Restricted Flow rate (1248)

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

Event Date 01/30/2015

Event Type  malfunction  

Event Description

The user reported that the peritoneal dialysis catheter would not drain.A fibrin sheath was removed from the inside of the catheter.The catheter continued to performed poorly and was replaced.No harm or injury to the pt was reported.

Manufacturer Narrative

Device eval: no device is expected to be returned for eval.Since the lot number was not provided, the device history record and complaint data base could not be reviewed.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and f/u submitted.

• Brand Name: FLEX-NECK ARC PERITONEAL DIALYSIS CATH
• Type of Device: CATHETER, PERITONEAL, LONG-TERM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 4567611
• MDR Text Key: 5559416
• Report Number: 1721504-2015-00050
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CF-5260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1