MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC CENTROSFLO LONG-TERM DIALYSIS CATHETER

Catalog Number CENF23K

Device Problem Split (2537)

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

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

One device is expected to be returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The user reported that a tear was noticed on the catheter after placement.The unit was replaced with no additional consequences to the patient.

Manufacturer Narrative

One unit was returned for evaluation.The device was inspected visually and microscopically.Simulated use testing was also performed.The complaint of a tear in the catheter is confirmed, however, the tear did not perforate the inner wall of the catheter.The unit did not leak during testing.The root cause could not be confirmed but is most likely from the catheter being clamped with hemostats.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: CENTROSFLO LONG-TERM DIALYSIS CATHETER
• Type of Device: LONG-TERM 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: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6001113
• MDR Text Key: 56506599
• Report Number: 1721504-2016-00191
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K141363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

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 Expiration Date: 10/30/2017
• Device Catalogue Number: CENF23K
• Device Lot Number: H756191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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