MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CATHETER.LONG-TERM HEMODIALYSIS CATHETER; LONG -TERM HEMODIALYSIS CATHETER

Catalog Number CENF23K

Device Problem Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Once the device has been returned evaluation.A review of the device history and complaint data base will be conducted.A follow up will be submitted upon completion of the investigation.

Event Description

Account reported they could not aspirate through the red hub of the catheter after placement.The device was replaced with another.No patient injury reported.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.A search of the complaint database and device history record could not be performed since the lot number was not provided.

• Brand Name: CATHETER.LONG-TERM HEMODIALYSIS CATHETER
• Type of Device: LONG -TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 w. merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6001346
• MDR Text Key: 56543336
• Report Number: 1721504-2016-00192
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CENF23K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1