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

Catalog Number CC-1301/A

Device Problems Fracture (1260); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2015

Event Type  malfunction  

Event Description

The user reported that the catheter adapter was cutting the catheter and had to be repaired.This damage had occurred six times over the past year and a half.The catheter is still being used by the patient.No harm or injury to the patient was reported.The implant date of (b)(6) 2014 is an estimate.

Manufacturer Narrative

Is this a single-use device that was reprocessed and reused on a patient? this information was not provided by the patient.Device evaluation.The evaluation of this complaint is in-process.A follow up report will be submitted once the evaluation has been completed.

Manufacturer Narrative

Device evaluation: the connector and a portion of the damaged catheter were returned for evaluation.The connector was observed under magnification.The connector had sharper edges than specified for the component.The complaint is confirmed.The sharp edge led to the catheter being damaged.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.

• Brand Name: FLEX-NECK PD CATHETER
• 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: 4870820
• MDR Text Key: 19989746
• Report Number: 1721504-2015-00105
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: CC-1301/A
• Device Lot Number: H584136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1