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

Catalog Number	H787108007015
Medical Device Problem Codes	Difficult to Flush (1251); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Angiodynamics notified the dialysis catheter manufacturer of this complaint event on (b)(6) 2017 via supplier corrective action request scar003185.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.The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint reference (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017: a patient had a dialysis catheter inserted with no report of complication or device malfunction.Post procedure, the surgeon noted the catheter did not function as intended.The catheter was removed and replaced with a new of the same device.The reported defective device has been returned to the manufacturer for an investigation.
Additional Manufacturer Narrative
Based on the sample evaluation by the supplier, this complaint no longer meets the criteria of a reportable event.One schon dialysis catheter was returned for evaluation and forwarded to our vendor for evaluation via (b)(4).Per (b)(4) vendor response, no leaks were detected on the returned sample.The customer's reported complaint cannot be confirmed.The incoming receiver lot record and the vendor manufacturing lot records both indicate that all device specification and quality requirements were met.Per (b)(4) vendor response, no leaks were detected on the returned sample.The customer's reported complaint cannot be confirmed.The instructions for use, which is supplied to the end user with this catalog number, states: "clamping the catheter repeatedly in the same spot could weaken the tubing.Change the position of the clamps regularly to prolong the life of the tubing." 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.Complaint reference (b)(4).

• Brand Name: SCHON XL DOUBLELUMEN CATHETER
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS
• Manufacturer (Section D): MARTECH MEDICAL PRODUCTS; 1500 delp drive; harleysville PA 19438
• MDR Report Key: 6572953
• Report Number: 1319211-2017-00054
• Device Sequence Number: 92208
• Product Code: MSD
• UDI-Device Identifier: H787108007015
• UDI-Public: H787108007015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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
• Operator of Device: Physician
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: H787108007015
• Device Lot Number: MHSR890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1