MAUDE Adverse Event Report: MARTECH MEDICAL PRODUCTS SCHON XL DOUBLE LUMEN CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS

Catalog Number H787108007025

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

Angiodynamics notified the dialysis catheter manufacturer of this complaint event on april 26, 2017 via supplier corrective action request (b)(4).As part of a review of complaints related to distribution only products, angiodynamics identified that it does not have objective evidence that the manufacturer assessed this complaint event for mdr reportability.As a result of this review, angiodynamics chose to assess this complaint event for reportability and determined that it does meet the criteria to file an mdr.This retrospective mdr is being filed based on this review and to ensure complaint file is complete.It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported to angiodynamics on april 25, 2017 via a user medwatch mw5068931: during a dialysis procedure, a hole in the patient's dialysis catheter was noted.The device was removed and replaced with a new of the same device.There were no adverse patient effects due to this event.It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The user medwatch did not contain any identifying complainant contact information.A search of the provided lot number revealed the reported lot had been shipped to multiple medical facilities, therefore angiodynamics is unable to identify the reporting complainant.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customers reported complaint of a hole in the catheter could not be confirmed because no sample was received for evaluation.Without a device evaluation, angiodynamics is unable to determine the root cause for the event.Angiodynamics' supplier was notified of this event via (b)(4).The supplier provided a dhr review that noted no abnormalities during the production of the device.The incoming receiver lot record and the vendor manufacturing lot records both indicate that all device specification and quality requirements were met.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: SCHON XL DOUBLE LUMEN CATHETER
• Type of Device: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS
• Manufacturer (Section D): MARTECH MEDICAL PRODUCTS; 1500 delp drive; harleysville PA 19438
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6556401
• MDR Text Key: 74992160
• Report Number: 1319211-2017-00048
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H787108007025
• UDI-Public: H787108007025
• Combination Product (y/n): N
• PMA/PMN Number: K971925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: H787108007025
• Device Lot Number: MHMD760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: 04/25/2017
• Supplement Dates FDA Received: 07/17/2017
• 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: Initial
• Patient Sequence Number: 1