• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MARTECH MEDICAL PRODUCTS SCHON XL DOUBLE LUMEN CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6556401
MDR Text Key74992160
Report Number1319211-2017-00048
Device Sequence Number1
Product Code MSD
UDI-Device IdentifierH787108007025
UDI-PublicH787108007025
Combination Product (y/n)N
PMA/PMN Number
K971925
Number of Events Reported1
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 Date09/30/2018
Device Catalogue NumberH787108007025
Device Lot NumberMHMD760
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/25/2017
Initial Date FDA Received05/10/2017
Supplement Dates Manufacturer Received04/25/2017
Supplement Dates FDA Received07/17/2017
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 Number1
-
-