MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC FLEX-NECK PERITONEAL DIALYSIS CATHETER

Catalog Number CF-5161

Device Problems Fracture (1260); Hole In Material (1293)

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

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: one device connector was returned for evaluation.The evaluation is in-process.A follow up report will be sent when the evaluation has been completed.

Event Description

The user reported that a hole in the catheter developed adjacent to the connector.The catheter connector was replaced.No patient harm or injury was reported.Implant date of (b)(6) 2015 is an estimate.

Manufacturer Narrative

One connector and a section of the catheter were returned for evaluation.The returned items were visually inspected and damage to the catheter was identified.The complaint is confirmed.The connector appeared to have sharper edges than is specified for the component.Two potential lot numbers were provided and the device history record was reviewed for both lots.No exception documents for these lot numbers were found.The complaint database was reviewed and no similar complaints for these lot numbers were found.Current inventory was visually inspected and the connector appeared to be within specification.

• Brand Name: FLEX-NECK PERITONEAL DIALYSIS CATHETER
• Type of Device: PERITONEAL DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 4953042
• MDR Text Key: 23198526
• Report Number: 1721504-2015-00127
• 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: Other
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CF-5161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• 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